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

NCT ID: NCT07010406

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-06
• Study Completion Date: 2025-08-19

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.).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A1: Povetacicept Bioavailability

Participants will be randomized to receive one of the two Povetacicept formulations.

Group Type: EXPERIMENTAL

Povetacicept

Intervention Type: DRUG

Injection for Subcutaneous Administration.

Part A2: Povetacicept Bioavailability

Participants will be randomized to receive one of the two Povetacicept formulations.

Group Type: EXPERIMENTAL

Povetacicept

Intervention Type: DRUG

Injection for Subcutaneous Administration.

Part B1: Povetacicept Bioequivalence

Participants will be randomized to receive one of the two Povetacicept presentations.

Group Type: EXPERIMENTAL

Povetacicept

Intervention Type: DRUG

Injection for Subcutaneous Administration.

Part B2: Povetacicept Bioequivalence

Participants will be randomized to receive one of the two Povetacicept presentations.

Group Type: EXPERIMENTAL

Povetacicept

Intervention Type: DRUG

Injection for Subcutaneous Administration.

Interventions

Povetacicept

Injection for Subcutaneous Administration.

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion - Tempe

Tempe, Arizona, United States

Celerion - Lincoln

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

VX24-AIS-D11

Identifier Type: -

Identifier Source: org_study_id