A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations
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
1 other identifier
interventional
136
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jun 2025
Shorter than P25 for phase_1 healthy-volunteers
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2025
CompletedStudy Start
First participant enrolled
June 6, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2025
CompletedSeptember 18, 2025
September 1, 2025
2 months
May 30, 2025
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept
From Day 1 up to Day 30
Maximum Observed Plasma Concentration (Cmax) of Free Povetacicept
From Day 1 up to Day 30
Secondary Outcomes (1)
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to Day 31
Study Arms (4)
Part A1: Povetacicept Bioavailability
EXPERIMENTALParticipants will be randomized to receive one of the two Povetacicept formulations.
Part A2: Povetacicept Bioavailability
EXPERIMENTALParticipants will be randomized to receive one of the two Povetacicept formulations.
Part B1: Povetacicept Bioequivalence
EXPERIMENTALParticipants will be randomized to receive one of the two Povetacicept presentations.
Part B2: Povetacicept Bioequivalence
EXPERIMENTALParticipants will be randomized to receive one of the two Povetacicept presentations.
Interventions
Injection for Subcutaneous Administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Celerion - Tempe
Tempe, Arizona, 85283, United States
Celerion - Lincoln
Lincoln, Nebraska, 68502, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2025
First Posted
June 8, 2025
Study Start
June 6, 2025
Primary Completion
August 19, 2025
Study Completion
August 19, 2025
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing