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

• ClinicalTrials.gov Identifier: NCT04616105
• Recruitment Status: Terminated
• First Posted: November 4, 2020
• Last Update Posted: November 11, 2021
• Sponsor: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

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 (Clinical Trial)
• 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: November 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 :

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

Secondary Outcome Measures :

1. Serum Concentration of REGN6490 over time [ Time Frame: Up to Week 16 ]
2. Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs) [ Time Frame: Up to Week 16 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Key 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

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/Exclusion criteria apply

Contacts and Locations

Locations

United States, California

Regeneron Study Site

Glendale, California, United States, 91206

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

More Information

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04616105
• Other Study ID Numbers: R6490-HV-1993
• First Posted: November 4, 2020
• Last Update Posted: November 11, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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
• URL: https://vivli.org/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No