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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04616105
• Other study ID #: R6490-HV-1993
• Status: Terminated
• Phase: Phase 1
• Start date: November 18, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: October 2021
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• REGN6490
Single dose of REGN6490
• Placebo
Placebo matching single dose of REGN6490

Locations

Country	Name	City	State
United States	Regeneron Study Site	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)	TEAEs include abnormal laboratory testing, vital signs and electrocardiograms (ECGs)	Up to Week 16
Secondary	Serum Concentration of REGN6490 over time		Up to Week 16
Secondary	Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)		Up to Week 16