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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07876505
- Acronym / sponsor ID
- R7508-HV-2628
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 15 Oct 2026 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Cenvacibart |
| Cohort 2 | Experimental | Drug: Cenvacibart |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| CenvacibartAlso: REGN7508Administered per the protocol | Drug | Cohort 1, Cohort 2 |
Primary outcome
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Time frame: Up to approximately day 57
Maximum observed concentration (Cmax)
Time frame: Up to approximately day 57
4 secondary outcomes
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately day 100
Severity of TEAEs
Time frame: Up to approximately day 100
Occurrence of Anti-Drug Antibody (ADA) to cenvacibart
Time frame: Up to approximately day 57
Magnitude of ADA to cenvacibart
Time frame: Up to approximately day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cenvacibart in people with Healthy Volunteers, run by Regeneron Pharmaceuticals.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) (time frame: Up to approximately day 57). 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 15 Oct 2026.