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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT04616105

Collaborator

(none)

Enrollment

Location

Arms

6.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: REGN6490 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 18, 2020

Actual Primary Completion Date :

May 28, 2021

Actual Study Completion Date :

May 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Single ascending subcutaneous (SC) dose 1 of REGN6490 or matching placebo	Drug: REGN6490 Single dose of REGN6490 Drug: Placebo Placebo matching single dose of REGN6490
Experimental: Cohort 2 Single ascending subcutaneous (SC) dose 2 of REGN6490 or matching placebo	Drug: REGN6490 Single dose of REGN6490 Drug: Placebo Placebo matching single dose of REGN6490
Experimental: Cohort 3 Single ascending subcutaneous (SC) dose 3 of REGN6490 or matching placebo	Drug: REGN6490 Single dose of REGN6490 Drug: Placebo Placebo matching single dose of REGN6490
Experimental: Cohort 4 Single ascending intravenous (IV) dose 4 of REGN6490 or matching placebo	Drug: REGN6490 Single dose of REGN6490 Drug: Placebo Placebo matching single dose of REGN6490

Outcome Measures

Primary Outcome Measures

Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Up to Week 16]
TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)

Secondary Outcome Measures

Serum Concentration of REGN6490 over time [Up to Week 16]
Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs) [Up to Week 16]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regeneron Study Site	Glendale	California	United States	91206

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04616105

Other Study ID Numbers:

R6490-HV-1993

First Posted:

Nov 4, 2020

Last Update Posted:

Nov 11, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 11, 2021