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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Povetacicept

• Registration Number: NCT07010406
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.

Detailed Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study Start: 2025-06-02
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2025-08-27
• Study Completion: 2025-08-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A1: Povetacicept Bioavailability	Povetacicept	Participants will be randomized to receive one of the two Povetacicept formulations.
Part A2: Povetacicept Bioavailability	Povetacicept	Participants will be randomized to receive one of the two Povetacicept formulations.
Part B1: Povetacicept Bioequivalence	Povetacicept	Participants will be randomized to receive one of the two Povetacicept presentations.
Part B2: Povetacicept Bioequivalence	Povetacicept	Participants will be randomized to receive one of the two Povetacicept presentations.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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