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NCT07876505
Healthy Adult Participants Trial Comparing Different Cenvacibart Presentations
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 80
Sponsor: Regeneron Pharmaceuticals
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
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-\ 24 hours) for any reason within 30 days of the screening visit
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Source: ClinicalTrials.gov (NCT07876505). StuddyBuddy aggregates publicly available trial information.