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Study · Non-randomized trial · 2020

14 results

A Randomized Double-Blind Placebo-Controlled First-In-Human Phase 1 Trial of TransCon PTH in Healthy Adults.

Karpf DB, Pihl S, Mourya S, Mortensen E, Kovoor E, Markova D, Leff JA

Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research16 Apr 2020Cited by 46 (Europe PMC)

PMID32212275 (opens in a new tab)PMCIDPMC9328939 (opens in a new tab)DOI10.1002/jbmr.4016 (opens in a new tab)PepBankPUB-32212275
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Summary

TransCon PTH is a sustained-release, essentially inactive prodrug transiently bound to an inert carrier, designed to release PTH(1-34), and in development for hypoparathyroidism (HP). This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults. SAD and MAD cohorts consisted of 10 subjects (eight active, two placebo) who received up to seven single or six multiple ascending doses of TransCon PTH, respectively. TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts. The primary PK endpoint was Free PTH. The PD endpoints included albumin adjusted serum calcium (sCa), fractional excretion of calcium (FECa), intact endogenous PTH(1-84), bone turnover markers, renal tubular maximum reabsorption of phosphate/glomerular filtration rate (TMP/GFR), serum phosphate (sP) and magnesium, and 1,25 dihydroxyvitamin D. TransCon PTH was generally well tolerated; there were no drug-related serious adverse events (SAEs), and all AEs were transient in nature. Free PTH demonstrated an effective half-life of approximately 60 hours and a dose-dependent, sustained exposure with an infusion-like profile within the calculated physiologic range for active PTH at steady-state. Albumin-adjusted sCa demonstrated a dose-dependent, sustained response with complete control of FECa despite modest hypercalcemia at higher doses. Renal tubular maximum reabsorption of phosphate/glomerular filtration rate (TMP/GFR) showed a dose-dependent decrease, resulting in a dose-dependent decrease in sP. TransCon PTH administered daily for 10 days showed no increase in the osteoblastic bone formation markers, serum bone-specific alkaline phosphatase (BSAP) or P1NP, or the osteoclastic bone resorption marker, urine NTx, but modestly and transiently increased the osteoclast marker, serum CTx. These phase 1 data support TransCon PTH as a daily replacement therapy for HP providing physiological levels of PTH 24 hours per day and advancement into phase 2 clinical development. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In healthy adults receiving TransCon PTH, free PTH had an effective half-life of approximately 60 hours.

    In plain wordsIn healthy adults receiving TransCon PTH, free PTH had an effective half-life of approximately 60 hours.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableFree PTH effective half-life
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Measurements

    Effective half-life
    ≈ 60 hours
    Free PTH

    Source sentences

    Summary
    Free PTH demonstrated an effective half-life of approximately 60 hours and a dose-dependent, sustained exposure with an infusion-like profile within the calculated physiologic range for active PTH at steady-state.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  2. 02HumanNon-randomized trialPharmacokinetics

    In healthy adults, TransCon PTH produced dose-dependent sustained free PTH exposure with an infusion-like steady-state profile within the calculated physiologic range.

    In plain wordsIn healthy adults, TransCon PTH produced sustained, dose-dependent free PTH exposure with an infusion-like profile within the calculated physiologic range.

    Peptide
    Palopegteriparatide
    Outcome
    Direction not reportedFree PTH exposure
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Free PTH demonstrated an effective half-life of approximately 60 hours and a dose-dependent, sustained exposure with an infusion-like profile within the calculated physiologic range for active PTH at steady-state.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  3. 03HumanNon-randomized trialSafety outcome

    In healthy adults, TransCon PTH was generally well tolerated.

    In plain wordsIn healthy adults, TransCon PTH was generally well tolerated.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    TransCon PTH was generally well tolerated; there were no drug-related serious adverse events (SAEs), and all AEs were transient in nature.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  4. 04HumanNon-randomized trialSafety outcome

    In healthy adults receiving TransCon PTH, no drug-related serious adverse events occurred.

    In plain wordsIn healthy adults receiving TransCon PTH, no drug-related serious adverse events occurred.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableDrug-related serious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    TransCon PTH was generally well tolerated; there were no drug-related serious adverse events (SAEs), and all AEs were transient in nature.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy adults receiving TransCon PTH, all adverse events were transient.

    In plain wordsIn healthy adults receiving TransCon PTH, all adverse events were temporary.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableAdverse event transience
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    TransCon PTH was generally well tolerated; there were no drug-related serious adverse events (SAEs), and all AEs were transient in nature.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  6. 06HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving TransCon PTH, albumin-adjusted serum calcium showed a sustained dose-dependent response with modest hypercalcemia at higher doses.

    In plain wordsIn healthy adults receiving TransCon PTH, serum calcium showed a sustained dose-dependent response, with modest hypercalcemia at higher doses.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseAlbumin-adjusted serum calcium
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Albumin-adjusted sCa demonstrated a dose-dependent, sustained response with complete control of FECa despite modest hypercalcemia at higher doses.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  7. 07HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving TransCon PTH, fractional calcium excretion remained controlled despite modest hypercalcemia at higher doses.

    In plain wordsIn healthy adults receiving TransCon PTH, calcium excretion remained controlled despite modest hypercalcemia at higher doses.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableFractional calcium excretion control
    Study

    n: not reported in source

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Albumin-adjusted sCa demonstrated a dose-dependent, sustained response with complete control of FECa despite modest hypercalcemia at higher doses.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  8. 08HumanNon-randomized trialSafety outcome

    In healthy adults receiving TransCon PTH, higher doses produced modest hypercalcemia.

    In plain wordsIn healthy adults receiving TransCon PTH, higher doses produced modest hypercalcemia.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseHypercalcemia at higher doses
    Study

    n: not reported in source

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Albumin-adjusted sCa demonstrated a dose-dependent, sustained response with complete control of FECa despite modest hypercalcemia at higher doses.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  9. 09HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving TransCon PTH, renal tubular phosphate reabsorption relative to glomerular filtration decreased with dose.

    In plain wordsIn healthy adults receiving TransCon PTH, kidney phosphate reabsorption decreased with dose.

    Peptide
    Palopegteriparatide
    Outcome
    DecreaseTMP/GFR
    Study

    n: not reported in source

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Renal tubular maximum reabsorption of phosphate/glomerular filtration rate (TMP/GFR) showed a dose-dependent decrease, resulting in a dose-dependent decrease in sP.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  10. 10HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving TransCon PTH, serum phosphate decreased with dose.

    In plain wordsIn healthy adults receiving TransCon PTH, serum phosphate decreased with dose.

    Peptide
    Palopegteriparatide
    Outcome
    DecreaseSerum phosphate
    Study

    n: not reported in source

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Renal tubular maximum reabsorption of phosphate/glomerular filtration rate (TMP/GFR) showed a dose-dependent decrease, resulting in a dose-dependent decrease in sP.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  11. 11HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving daily TransCon PTH for 10 days, serum bone-specific alkaline phosphatase did not increase.

    In plain wordsIn healthy adults receiving daily TransCon PTH for 10 days, a bone formation marker, bone-specific alkaline phosphatase, did not increase.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableSerum bone-specific alkaline phosphatase
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 10 daysAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH administered daily for 10 days showed no increase in the osteoblastic bone formation markers, serum bone-specific alkaline phosphatase (BSAP) or P1NP, or the osteoclastic bone resorption marker, urine NTx, but modestly and transiently increased the osteoclast marker, serum CTx.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  12. 12HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving daily TransCon PTH for 10 days, P1NP did not increase.

    In plain wordsIn healthy adults receiving daily TransCon PTH for 10 days, the bone formation marker P1NP did not increase.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableP1NP
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 10 daysAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH administered daily for 10 days showed no increase in the osteoblastic bone formation markers, serum bone-specific alkaline phosphatase (BSAP) or P1NP, or the osteoclastic bone resorption marker, urine NTx, but modestly and transiently increased the osteoclast marker, serum CTx.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  13. 13HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving daily TransCon PTH for 10 days, urinary NTx did not increase.

    In plain wordsIn healthy adults receiving daily TransCon PTH for 10 days, the bone resorption marker urinary NTx did not increase.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableUrinary NTx
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 10 daysAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH administered daily for 10 days showed no increase in the osteoblastic bone formation markers, serum bone-specific alkaline phosphatase (BSAP) or P1NP, or the osteoclastic bone resorption marker, urine NTx, but modestly and transiently increased the osteoclast marker, serum CTx.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.
  14. 14HumanNon-randomized trialEfficacy outcome

    In healthy adults receiving daily TransCon PTH for 10 days, serum CTx increased modestly and transiently.

    In plain wordsIn healthy adults receiving daily TransCon PTH for 10 days, the bone marker serum CTx increased modestly and temporarily.

    Peptide
    Palopegteriparatide
    Outcome
    IncreaseSerum CTx
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    Dose not stated · 10 daysAs given in this study (human).

    Source sentences

    Summary
    TransCon PTH administered daily for 10 days showed no increase in the osteoblastic bone formation markers, serum bone-specific alkaline phosphatase (BSAP) or P1NP, or the osteoclastic bone resorption marker, urine NTx, but modestly and transiently increased the osteoclast marker, serum CTx.
    2 context sentences
    Summary · context
    This phase 1, randomized, placebo-controlled, single and multiple ascending dose (SAD and MAD, respectively) trial evaluated safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of TransCon PTH in healthy adults.
    Summary · context
    TransCon PTH doses ranged from 3.5 to 124 μg PTH(1-34) for the SAD cohorts and 3.5 to 24 μg PTH(1-34)/day for the MAD cohorts.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedNCT07299838

Palopegteriparatide in Chronic Hypoparathyroidism

National and Kapodistrian University of Athensn = 901 Jun 2024 to 23 Oct 2025

Hypoparathyroidism

Trial pageClinicalTrials.govUpdated 26 Jan 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:37 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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