A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations

NCT07010406
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Phase
Phase 1
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Recruitment status
Completed
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Participants
136
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Start date
2025-06-06
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Number of sites
2
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Summary
The purpose of this study is to evaluate the relative bioavailability of Povetacicept formulations, bioequivalence of Povetacicept presentations, and safety and tolerability of Povetacicept.
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Short title
A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations
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Official title
A Phase 1, Open-label, Randomized, 2-part Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations in Healthy Subjects
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-08-19
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First posted
2025-06-08
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Registry last updated
2025-09-18
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Primary completion date
2025-08-19
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Start date
2025-06-06
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Actual participants
136
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Participants
136
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
2
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Registry sponsor category
Industry
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07010406
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ClinicalTrials.gov ID
NCT07010406
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept

    Timeframe: From Day 1 up to Day 30

  2. Maximum Observed Plasma Concentration (Cmax) of Free Povetacicept

    Timeframe: From Day 1 up to Day 30

  1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: From Day 1 up to Day 31

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

Key Inclusion Criteria:

  • Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive
  • A total body weight of more than (>) 50 kg

Key Exclusion Criteria:

  • History of febrile illness that has not fully resolved within 14 days before the dose of study drug.
  • Immunization with a live vaccine within 45 days before study drug administration or a non live vaccine within 14 days before study drug administration.

Other protocol defined Inclusion/Exclusion criteria may apply.

Sources for eligibility
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  • Celerion - TempeTempe, United States
  • Celerion - LincolnLincoln, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)