Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Adult Volunteers

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the safety and tolerability of 3 single ascending subcutaneous (SC) doses and 1 single intravenous (IV) dose of REGN6490 in healthy first-generation Japanese adult participants The secondary objectives of the study are: To characterize the pharmacokinetic (PK) profile of single SC and IV doses of REGN6490 in healthy first-generation Japanese adult participants Assess immunogenicity of REGN6490 in healthy first-generation Japanese adult participants dosed with a single IV or SC dose of REGN6490

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: REGN6490
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Is a male or female first-generation Japanese participant 20 to 60 years of age (inclusive) at screening visit. First-generation Japanese subject must: (a) Be Japanese, born in Japan, and have both biologic parents and 4 biologic grandparents who are ethnically Japanese and born in Japan, (b) Have maintained a Japanese lifestyle, with no significant change since leaving Japan, including having access to Japanese food and adhering to a Japanese diet, (c) Have lived <10 years outside of Japan Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit 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 Is in good health based on laboratory safety testing obtained at the screening visit Willing and able to comply with clinic visits and study-related procedures Provide informed consent signed by study participant Key Exclusion Criteria: 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 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 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 Hospitalization (>24 hours) for any reason within 30 days of the screening visit 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/Exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single ascending subcutaneous (SC) dose 1 of REGN6490 or matching placebo | Drug: REGN6490<br>* Single dose of REGN6490<br>Drug: Placebo<br>* Placebo matching single dose of REGN6490<br>|
| Experimental: Cohort 2<br>Single ascending subcutaneous (SC) dose 2 of REGN6490 or matching placebo | Drug: REGN6490<br>* Single dose of REGN6490<br>Drug: Placebo<br>* Placebo matching single dose of REGN6490<br>|
| Experimental: Cohort 3<br>Single ascending subcutaneous (SC) dose 3 of REGN6490 or matching placebo | Drug: REGN6490<br>* Single dose of REGN6490<br>Drug: Placebo<br>* Placebo matching single dose of REGN6490<br>|
| Experimental: Cohort 4<br>Single ascending intravenous (IV) dose 4 of REGN6490 or matching placebo | Drug: REGN6490<br>* Single dose of REGN6490<br>Drug: Placebo<br>* Placebo matching single dose of REGN6490<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) | TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs) | Up to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |