NCT07526116
Not yet recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 64
- Primary Endpoint
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Overview
Brief Summary
This clinical study will evaluate the study drug, REGN22044, in healthy participants. REGN22044 has not previously been studied in humans.
The purpose of this study is to learn:
- What side effects may happen when REGN22044 is taken
- How much of REGN22044 is in the blood at different times
- Whether the body makes antibodies against REGN22044 (which could make the drug less effective or could lead to side effects)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1\. Is judged by the investigator to be in good health as described in the protocol
Exclusion Criteria
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator
- •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
- •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
- •Evidence of active or latent tuberculosis (TB) as documented by medical history and examination
- •Note: Other protocol defined Inclusion/ Exclusion criteria apply.
Arms & Interventions
Subcutaneous (SC) Cohorts
Experimental
Intervention: Placebo (Drug)
Subcutaneous (SC) Cohorts
Experimental
Intervention: REGN22044 (Drug)
Intravenous (IV) Cohorts
Experimental
Intervention: REGN22044 (Drug)
Intravenous (IV) Cohorts
Experimental
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 18 weeks
Severity of TEAEs
Time Frame: Up to 18 weeks
Secondary Outcomes
- Concentration of REGN22044 in serum(Up to 18 weeks)
Investigators
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