Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

NCT ID: NCT03645746

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-23
• Study Completion Date: 2019-09-30

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.

The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

Cohort 1 will receive a single IV dose of REGN5069 or matching placebo

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

REGN5069 will be administered by IV infusion or SC injection

Placebo

Intervention Type: DRUG

Placebo-matching REGN5069

Cohort 2

Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

REGN5069 will be administered by IV infusion or SC injection

Placebo

Intervention Type: DRUG

Placebo-matching REGN5069

Cohort 3

Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

REGN5069 will be administered by IV infusion or SC injection

Placebo

Intervention Type: DRUG

Placebo-matching REGN5069

Cohort 4

Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

REGN5069 will be administered by IV infusion or SC injection

Placebo

Intervention Type: DRUG

Placebo-matching REGN5069

Cohort 5

Cohort 5 will receive a single SC dose of REGN5069 or matching placebo

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

REGN5069 will be administered by IV infusion or SC injection

Placebo

Intervention Type: DRUG

Placebo-matching REGN5069

Cohort 6

Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

REGN5069 will be administered by IV infusion or SC injection

Placebo

Intervention Type: DRUG

Placebo-matching REGN5069

Cohort 7

Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

REGN5069 will be administered by IV infusion or SC injection

Placebo

Intervention Type: DRUG

Placebo-matching REGN5069

Interventions

REGN5069

REGN5069 will be administered by IV infusion or SC injection

Intervention Type: DRUG

Placebo

Placebo-matching REGN5069

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing
• Participant 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 or legally acceptable representative

Exclusion Criteria

• History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease
• Has any physical examination findings and/or history of any illness that might confound the results of the study or poses an additional risk to the subject by study participation
• Hospitalization for any reason within 60 days of the screening visit
• Current cigarette smoker or former smoker (cigarettes or e-cigarettes) who stopped smoking within 3 months prior to screening
• History of drug or alcohol abuse within a year prior to the screening visit
• Presence of HIV, hepatitis B, or hepatitis C seropositivity at screening or within 3 months prior to dosing with the exception of false positive screening tests as documented by polymerase chain reaction or Western blot
• Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus, that have been resected, with no evidence of metastatic disease for 3 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Research Facility

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2018-000651-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R5069-HV-1810

Identifier Type: -

Identifier Source: org_study_id