ClinicalTrials.gg
Not yet recruitingNCT07876505Updated Oct 15, 2026

Healthy Adult Participants Trial Comparing Different Cenvacibart Presentations

A Phase 1 interventional study of Cenvacibart in Healthy Volunteers, sponsored by Regeneron Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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
02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 409 studies on the registry; 92 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. 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
  2. Is in good health based on laboratory safety testing obtained at the screening visit and/or prior to randomization
  3. 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:

  1. 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
  2. Has a sensitivity to any of the trial interventions, or components thereof, in the opinion of the investigator, that contraindicates participation in the trial
  3. Has donated whole blood within the previous 56 days or plasma donation within the previous 7 days prior to screening visit
  4. 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
  5. Was hospitalized (ie, > 24 hours) for any reason within 30 days of the screening visit

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    Drug: Cenvacibart

  • Experimental
    Cohort 2

    Drug: Cenvacibart

Interventions

  • Administered per the protocol

    Also known as: REGN7508

06

What researchers measure

Primary outcomes

  1. Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)

    Time frame: Up to approximately day 57

  2. Maximum observed concentration (Cmax)

    Time frame: Up to approximately day 57

Secondary outcomes

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately day 100

  2. Severity of TEAEs

    Time frame: Up to approximately day 100

  3. Occurrence of Anti-Drug Antibody (ADA) to cenvacibart

    Time frame: Up to approximately day 57

  4. Magnitude of ADA to cenvacibart

    Time frame: Up to approximately day 57

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy

Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 15, 2026
StartEst.
Nov 23, 2026
Primary completionEst.
Mar 23, 2027
CompletionEst.
May 14, 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876505
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Nov 23, 2026 (estimated)
Primary completion
Mar 23, 2027 (estimated)
Completion
May 14, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Cenvacibart

Start the discussion