Healthy VolunteersPhase 1NCT07010406
A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations
A Phase 1 study testing Povetacicept in people with Healthy Volunteers, run by Vertex Pharmaceuticals Incorporated at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Povetacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2025to 19 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion - Lincoln
Lincoln, Nebraska, 68502
Celerion - Tempe
Tempe, Arizona, 85283
About this study
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
The purpose of this study is to evaluate the relative bioavailability of Povetacicept formulations, bioequivalence of Povetacicept presentations, and safety and tolerability of Povetacicept.
Read the 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
- Being tested
- Povetacicept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PovetaciceptDrug
Injection for Subcutaneous Administration.
| Study group | Role | What they receive |
|---|---|---|
| Part A1: Povetacicept Bioavailability | Experimental | Participants will be randomized to receive one of the two Povetacicept formulations. Receives: Drug: Povetacicept |
| Part A2: Povetacicept Bioavailability | Experimental | Participants will be randomized to receive one of the two Povetacicept formulations. Receives: Drug: Povetacicept |
| Part B1: Povetacicept Bioequivalence | Experimental | Participants will be randomized to receive one of the two Povetacicept presentations. Receives: Drug: Povetacicept |
| Part B2: Povetacicept Bioequivalence | Experimental | Participants will be randomized to receive one of the two Povetacicept presentations. Receives: Drug: Povetacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept
Measured: From Day 1 up to Day 30
Maximum Observed Plasma Concentration (Cmax) of Free Povetacicept
Measured: 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)
Measured: From Day 1 up to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start6 Jun 2025
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010406
- Sponsor's protocol ID
- VX24-AIS-D11
- Status last verified
- Sep 2025
- First submitted
- 30 May 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07010406
- Acronym / sponsor ID
- VX24-AIS-D11
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A1: Povetacicept Bioavailability | Experimental | Drug: PovetaciceptParticipants will be randomized to receive one of the two Povetacicept formulations. |
| Part A2: Povetacicept Bioavailability | Experimental | Drug: PovetaciceptParticipants will be randomized to receive one of the two Povetacicept formulations. |
| Part B1: Povetacicept Bioequivalence | Experimental | Drug: PovetaciceptParticipants will be randomized to receive one of the two Povetacicept presentations. |
| Part B2: Povetacicept Bioequivalence | Experimental | Drug: PovetaciceptParticipants will be randomized to receive one of the two Povetacicept presentations. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PovetaciceptInjection for Subcutaneous Administration. | Drug | Part A1: Povetacicept Bioavailability, Part A2: Povetacicept Bioavailability, Part B1: Povetacicept Bioequivalence, Part B2: Povetacicept Bioequivalence |
Primary outcome
Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept
Time frame: From Day 1 up to Day 30
Maximum Observed Plasma Concentration (Cmax) of Free Povetacicept
Time frame: From Day 1 up to Day 30
1 secondary outcome
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No. 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
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Povetacicept in people with Healthy Volunteers, run by Vertex Pharmaceuticals Incorporated at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept (time frame: From Day 1 up to Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.