Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: REGN5069

Study type: Interventional

Funder types: Industry

Identifiers

NCT03645746

2018-000651-41 (EudraCT Number)

R5069-HV-1810

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Note: Other protocol Inclusion/Exclusion Criteria apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

56 participants in 7 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN5069

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN5069

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN5069

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN5069

Cohort 5

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN5069

Cohort 6

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN5069

Cohort 7

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN5069