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

NCT04616105 | Terminated Phase 1 FDA Drug

• 1 other identifier: R6490-HV-1993
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

  TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)

  Up to Week 16

Secondary Outcomes (2)

• Serum Concentration of REGN6490 over time

  Up to Week 16

• Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)

  Up to Week 16

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: REGN6490; Drug: Placebo

Cohort 2

EXPERIMENTAL

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

Drug: REGN6490; Drug: Placebo

Cohort 3

EXPERIMENTAL

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

Drug: REGN6490; Drug: Placebo

Cohort 4

EXPERIMENTAL

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

Drug: REGN6490; Drug: Placebo

Interventions

REGN6490 DRUG

Single dose of REGN6490

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Placebo matching single dose of REGN6490

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Study Site

Glendale, California, 91206, United States

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: November 18, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (1)