First-in-human test of REGN22044 safety and how it behaves in the body
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN22044 in Healthy Adult Participants
Run by Regeneron Pharmaceuticals · NCT07526116 · Data updated 2026-11-12
This first-in-human study will test REGN22044 in healthy adults to see if it is safe, tolerable, and how much stays in the blood after a single dose (with a placebo comparison).
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Status | Recruiting |
| Started | June 5, 2026 |
| Main results expected | February 8, 2027 |
| Study ends | February 8, 2027 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07526116 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults without significant medical or infectious disease histories who meet the protocol's health criteria and are able to comply with study procedures.
✕Probably not a fit
Participants with cardiovascular, hepatic, renal, or other significant health issues, or those with recent infections or on restricted medications, are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional study conducted in healthy volunteers to evaluate a single-dose REGN22044. The trial will monitor safety, tolerability, and pharmacokinetics, including blood levels over time and any potential antibody formation against REGN22044. Participants will be assigned to receive either the study drug or placebo, with careful screening to exclude significant medical conditions. Enrollment is limited to a site in Ghent, Belgium, led by Regeneron Pharmaceuticals. The study is not designed to assess efficacy for a disease condition but to establish initial human safety and drug behavior parameters.
Why it matters
Potential benefit: If successful, the study could establish that REGN22044 is safe at a single dose and characterize its behavior in the body, informing future research in humans.
How similar studies have gone: Previous first-in-human studies for monoclonal antibodies have shown that PK and safety data from healthy volunteers can support later development, but REGN22044 here is being studied in its initial human exposure.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1\. Is judged by the investigator to be in good health as described in the protocol Key Exclusion Criteria: 1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator 2. Use of any prescription or non-prescription medications or nutritional supplements from approximately 14 days or 5 half-lives, whichever is longer, prior to administration of study intervention or any planned use through the end of the study, except the permitted medications as listed in the protocol 3. Participants with fever (\>38°C) associated with infection, or chronic, persistent, or recurring infection(s) requiring active treatment with antibiotics, antivirals or antifungals within 8 weeks prior to the screening visit or the randomization visit, or other frequent recurrent infections deemed unacceptable as per investigator judgment 4. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination Note: Other protocol defined Inclusion/ Exclusion criteria apply.
Where it's running
-
Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium Recruiting
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.