Clinical trial NCT04616105: Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Adult Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN6490 in Healthy Japanese Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 16
Secondary outcomes:
measure: Serum Concentration of REGN6490 over time
timeFrame: Up to Week 16
measure: Incidence of Treatment-Emergent REGN6490 Anti-Drug Antibodies (ADAs)
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Regeneron Study Site
state: California
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: