Skip to content

Study · Randomized controlled trial · 2018

8 results

A first-in-man safety and pharmacokinetics study of nangibotide, a new modulator of innate immune response through TREM-1 receptor inhibition.

Cuvier V, Lorch U, Witte S, Olivier A, Gibot S, Delor I, Garaud JJ, Derive M, Salcedo-Magguilli M

British journal of clinical pharmacology20 Jul 2018Cited by 38 (Europe PMC)

PMID29885068 (opens in a new tab)PMCIDPMC6138490 (opens in a new tab)DOI10.1111/bcp.13668 (opens in a new tab)PepBankPUB-29885068
Source linkPubMedAsk about this study
Jump to 8 results

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy subjects, nangibotide was safe and well tolerated up to the highest tested dose.

    In plain wordsIn healthy subjects, nangibotide was safe and well tolerated up to the highest tested dose.

    Peptide
    Nangibotide
    Outcome
    Not applicableSafety and tolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Source sentences

    Summary
    Nangibotide was safe and well tolerated up to the highest dose tested.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy subjects, few adverse events occurred with nangibotide, and they were mild and considered unrelated to treatment.

    In plain wordsIn healthy subjects, few adverse events occurred with nangibotide, and they were mild and considered unrelated to treatment.

    Peptide
    Nangibotide
    Outcome
    Not applicableAdverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Source sentences

    Summary
    There were only few adverse events and they were mild in severity and considered unrelated to treatment.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, nangibotide displayed dose-proportional pharmacokinetics.

    In plain wordsIn healthy subjects, nangibotide exposure was proportional to dose.

    Peptide
    Nangibotide
    Outcome
    Not applicableDose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Source sentences

    Summary
    Nangibotide displayed dose-proportional PK properties, with a clearance of 6.6 l kg-1  h-1 for a subject of 70 kg and a 3 min effective half-life, which are compatible with extensive enzymatic metabolism in blood.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, nangibotide clearance was 6.6 l/kg/h for a subject of 70 kg.

    In plain wordsIn healthy subjects, nangibotide clearance was 6.6 l/kg/h for a subject of 70 kg.

    Peptide
    Nangibotide
    Outcome
    Not applicableClearance
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Measurements

    Clearance
    6.6 l kg^-1 h^-1
    subject of 70 kg

    Source sentences

    Summary
    Nangibotide displayed dose-proportional PK properties, with a clearance of 6.6 l kg-1  h-1 for a subject of 70 kg and a 3 min effective half-life, which are compatible with extensive enzymatic metabolism in blood.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, nangibotide had an effective half-life of 3 min.

    In plain wordsIn healthy subjects, nangibotide had an effective half-life of 3 min.

    Peptide
    Nangibotide
    Outcome
    Not applicableEffective half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Measurements

    Effective half-life
    3 min
    healthy subjects

    Source sentences

    Summary
    Nangibotide displayed dose-proportional PK properties, with a clearance of 6.6 l kg-1  h-1 for a subject of 70 kg and a 3 min effective half-life, which are compatible with extensive enzymatic metabolism in blood.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, nangibotide central volume of distribution was 16.7 l.

    In plain wordsIn healthy subjects, nangibotide central volume of distribution was 16.7 l.

    Peptide
    Nangibotide
    Outcome
    Not applicableCentral volume of distribution
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Measurements

    Central volume of distribution
    16.7 l
    healthy subjects

    Source sentences

    Summary
    Central and peripheral volumes of distribution were 16.7 l and 15.9 l respectively, indicating limited distribution of the drug mainly in blood and interstitial fluid.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…
  7. 07HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, nangibotide peripheral volume of distribution was 15.9 l.

    In plain wordsIn healthy subjects, nangibotide peripheral volume of distribution was 15.9 l.

    Peptide
    Nangibotide
    Outcome
    Not applicablePeripheral volume of distribution
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Measurements

    Peripheral volume of distribution
    15.9 l
    healthy subjects

    Source sentences

    Summary
    Central and peripheral volumes of distribution were 16.7 l and 15.9 l respectively, indicating limited distribution of the drug mainly in blood and interstitial fluid.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…
  8. 08HumanRandomized controlled trialSafety outcome

    In healthy subjects, no circulating anti-drug antibodies were detectable up to 28 days after nangibotide administration.

    In plain wordsIn healthy subjects, no anti-drug antibodies were detectable up to 28 days after nangibotide administration.

    Peptide
    Nangibotide
    Outcome
    Not applicableAnti-drug antibodies
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1 or 10 mg, or 0.03 to 6 mg/kg/h preceded by a loading dose of up to 5 mg/kg · intravenous infusion · 15 min, or 7 h 45 min preceded by a 15-minute loading doseAs given in this study (human).

    Source sentences

    Summary
    No circulating anti-drug antibodies were detectable up to 28 days after administration.
    1 context sentence
    Summary · context
    This first-in-man, randomized, double-blind, ascending dose, placebo-controlled Phase I study evaluated the safety, tolerability and pharmacokinetics of nangibotide.MethodsTwenty-seven healthy subjects (aged 18-45 years) were randomized into eight groups. Nangibotide was administered as a s…

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

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 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.