A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGN22044, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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)
Interventions
- Drug REGN22044
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to 18 weeks]
- Severity of TEAEs [Time frame: Up to 18 weeks]
Secondary outcome measures (1)
- Concentration of REGN22044 in serum [Time frame: Up to 18 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07526116 · R22044-HV-2533 · 2025-523562-24-00