Trial · Interventional
CompletedPhase 1Registry dataPharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 12 participants (actual)
- Sponsor
- Protagonist Therapeutics, Inc. · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
Australia
- Start
- 14 Sept 2020
- Primary completion
- 12 Jan 2021
- Completion
- 30 Jun 2021
- First posted
- 18 Aug 2020
- Last update posted
- 16 Sept 2021
- Conditions
- Healthy Volunteers
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
NCT0451638214 Sept 2020 to 30 Jun 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To estimate the bioavailability of PTG-300 following subcutaneous and intramuscular administration in healthy volunteers.
Interventions
- PTG-300Drug
Arms4
Experimental
Intravenous
PTG-300 Intravenous
Experimental
Subcutaneous Low Concentration
PTG-300 Subcutaneous Low Concentration
Experimental
Subcutaneous High Concentration
PTG-300 Subcutaneous High Concentration
Experimental
Intramuscular
PTG-300 Intramuscular
Primary outcomes1
Outcomes the sponsor listed as primary.
Bioavailability of PTG-300
Time frame · Week 1
Registry description
Bioavailability (area under the plasma-concentration time) of PTG-300 following subcutaneous and intramuscular administration in healthy volunteers
Secondary outcomes(2)
Serum Iron Pharmacodynamics of PTG-300
Time frame · Week 1
Registry description
Change from baseline in serum iron following subcutaneous and intramuscular administration in healthy volunteers
TSAT Pharmacodynamics of PTG-300
Time frame · Week 1
Registry description
Change from baseline in transferrin saturation (TSAT) following subcutaneous and intramuscular administration in healthy volunteers
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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