About this trial
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)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
REGN22044
DrugAdministered per the protocol
Placebo
DrugAdministered per the protocol
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Severity of TEAEs
Secondary outcomes
Concentration of REGN22044 in serum
Sponsors and contacts
Click on the lead sponsor to view all of their trials.