> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-relative-bioavailability-of-aa6e20ca-3b97-4b8c-8186-ae3fdf16c67a > Record changed: 2026-11-04 # A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations NCT07010406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) Participants 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) Lead sponsor Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) Start date 2025-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Short title** A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Dates **Completion date** 2025-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **First posted** 2025-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Registry last updated** 2025-09-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Primary completion date** 2025-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Start date** 2025-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Size and sites **Actual participants** 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Participants** 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Lead sponsor** Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Identifiers **Registry ID** NCT07010406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **ClinicalTrials.gov ID** NCT07010406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Sites - Celerion - TempeTempe, United States - Celerion - LincolnLincoln, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07010406) ## Related records ### Drugs (1) - [Povetacicept](https://trialight.com/data/asset/povetacicept-35bc1784-7c86-451c-9e1d-f9af96cfc0f6.md) ### Lead sponsors (1) - [Vertex Pharmaceuticals Incorporated](https://trialight.com/data/company/vertex-pharmaceuticals-incorporated-871a0178-8d63-4b70-a78f-fbfa131729c0.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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