Healthy VolunteersPhase 1NCT07876505
Healthy Adult Participants Trial Comparing Different Cenvacibart Presentations
A Phase 1 study testing Cenvacibart in people with Healthy Volunteers, run by Regeneron Pharmaceuticals.
Trial summary
This trial is being done in non-obese healthy participants to compare two different forms of cenvacibart. The main goal of the trial is to learn about the trial medicine and how it is absorbed, modified, and removed from the body. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cenvacibart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2026to 14 May 2027
- Phase
- Phase 1
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is judged by the investigator to be in good health based on medical history, physical examination, laboratory tests, vital sign measurements, and electrocardiogram (ECG)performed at screening and/or prior to randomization as described in the protocol
- Is in good health based on laboratory safety testing obtained at the screening visit and/or prior to randomization
- Has a body weight within 50.0 and 95.0 kg (inclusive) and body mass index (BMI) within the range ≥18.5-<32 kg/m^2 at the screening visit
Who cannot join
- Has a history of any major surgical procedure or clinically significant physical trauma within the last 6 months that, in the opinion of the investigator, may pose a risk to the participant by trial participation
- Has a sensitivity to any of the trial interventions, or components thereof, in the opinion of the investigator, that contraindicates participation in the trial
- Has donated whole blood within the previous 56 days or plasma donation within the previous 7 days prior to screening visit
- Has a history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confound the results of the trial or poses an additional risk to the participant by trial participation
- Was hospitalized (ie, > 24 hours) for any reason within 30 days of the screening visit
- Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Open-Label, Single-Dose Trial to Compare the Pharmacokinetics, Safety, and Tolerability of Different Cenvacibart (REGN7508) Presentations in Healthy Participants
This trial is being done in non-obese healthy participants to compare two different forms of cenvacibart.
The main goal of the trial is to learn about the trial medicine and how it is absorbed, modified, and removed from the body.
The trial will look at:
- What side effects cenvacibart might cause and how it feels after the dose
- Levels of cenvacibart in the blood at different time points
- Whether the body makes proteins called antibodies against cenvacibart (which could make the trial medicine less effective or could lead to side effects)
- What happens when cenvacibart travels through the body
- Conditions
- Healthy Volunteers
- Being tested
- Cenvacibart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenvacibartDrug
Also called REGN7508
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: Cenvacibart |
| Cohort 2 | Experimental | Not described Receives: Drug: Cenvacibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Measured: Up to approximately day 57
Maximum observed concentration (Cmax)
Measured: Up to approximately day 57
Secondary outcomes (4)
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately day 100
Severity of TEAEs
Measured: Up to approximately day 100
Occurrence of Anti-Drug Antibody (ADA) to cenvacibart
Measured: Up to approximately day 57
Magnitude of ADA to cenvacibart
Measured: Up to approximately day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start23 Nov 2026 (estimated)
- Primary completion23 Mar 2027 (estimated)
- Study completion14 May 2027 (estimated)
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 Regeneron PharmaceuticalsThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876505
- Sponsor's protocol ID
- R7508-HV-2628
- Other IDs
- 2026-527408-26-00
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.