Healthy Volunteer
Conditions
Brief summary
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN6490 in healthy adult participants The secondary objectives of the study are to: * Characterize the pharmacokinetic (PK) profile of single IV and SC doses of REGN6490 in healthy adult participants * Assess immunogenicity of REGN6490 in healthy adult participants dosed with a single IV or SC dose of REGN6490
Interventions
DRUGREGN6490
Single dose of REGN6490
DRUGPlacebo
Placebo matching single dose of REGN6490
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit 2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG's performed at screening and/or prior to administration of initial dose of study drug 3. Is in good health based on laboratory safety testing obtained at the screening visit 4. Willing and able to comply with clinic visits and study-related procedures 5. Provide informed consent signed by study participant Key
Exclusion criteria
1. History of clinically significant cardiovascular, dermatological, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation 2. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study 3. Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by study participation 4. Hospitalization (\>24 hours) for any reason within 30 days of the screening visit 5. Is a current smoker, including e-cigarettes. Former smokers may be enrolled if they have stopped smoking for at least 3 months (90 days) prior to the screening visit Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) | Up to Week 16 | TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs) |
Secondary
| Measure | Time frame |
|---|---|
| Serum Concentration of REGN6490 over time | Up to Week 16 |
| Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs) | Up to Week 16 |
Countries
Belgium
Outcome results
None listed