Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers
- Registration Number
- NCT03645746
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 REGN5069 Cohort 1 will receive a single IV dose of REGN5069 or matching placebo Cohort 1 Placebo Cohort 1 will receive a single IV dose of REGN5069 or matching placebo Cohort 2 REGN5069 Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 2 Placebo Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 3 REGN5069 Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 7 REGN5069 Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 3 Placebo Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 4 REGN5069 Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 4 Placebo Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 5 Placebo Cohort 5 will receive a single SC dose of REGN5069 or matching placebo Cohort 6 Placebo Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo Cohort 7 Placebo Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo Cohort 5 REGN5069 Cohort 5 will receive a single SC dose of REGN5069 or matching placebo Cohort 6 REGN5069 Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo
- Primary Outcome Measures
Name Time Method Incidence of laboratory abnormalities From baseline up to week 36 As measured by chemistry, hematology and urinalysis
Incidence and severity of treatment-emergent adverse events (TEAEs) From baseline up to week 36 Incidence of vital signs abnormalties From baseline up to week 36 As measured by heart rate, blood pressure, body temperature and respiratory rate
Incidence of standard 12-lead electrocardiogram (ECG) abnormalties From baseline up to week 36 As measured by heart rate, PR, complex of Q, R, and S waves \[QRS\], QT-intervals, and QTc
- Secondary Outcome Measures
Name Time Method Concentration of REGN5069 in serum over time From baseline up to week 36 Incidence of anti-drug antibody (ADA) From baseline up to week 36
Trial Locations
- Locations (1)
Regeneron Research Facility
🇧🇪Gent, Belgium