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

NCT ID: NCT04616105

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-05-28

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

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

Single ascending subcutaneous (SC) dose 1 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

Cohort 2

Single ascending subcutaneous (SC) dose 2 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

Cohort 3

Single ascending subcutaneous (SC) dose 3 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

Cohort 4

Single ascending intravenous (IV) dose 4 of REGN6490 or matching placebo

Group Type EXPERIMENTAL

REGN6490

Intervention Type DRUG

Single dose of REGN6490

Placebo

Intervention Type DRUG

Placebo matching single dose of REGN6490

Interventions

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REGN6490

Single dose of REGN6490

Intervention Type DRUG

Placebo

Placebo matching single dose of REGN6490

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Body mass index between 18 and 31 kg/m2 (inclusive) at screening visit
3. 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
4. Is in good health based on laboratory safety testing obtained at the screening visit
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide informed consent signed by study participant

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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R6490-HV-1993

Identifier Type: -

Identifier Source: org_study_id