Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers
- Registration Number
- NCT03115996
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.
- Detailed Description
Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
A subject must meet the follow criteria to be eligible for inclusion in the study:
- Males and females from 18 to 50 years of age.
- Subject is judged to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
- The subject has a body mass index less than 30 kg/m2
- Willingness to undergo vaccination and antibiotic prophylaxis against N. meningitides.
Key
A subject who meets any of the following criteria will be excluded from the study:
- Any clinically significant physical examination abnormalities observed during the screening visit.
- Hospitalization for any reason within 30 days of the screening visit
- Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals.
- Subject has a history of meningococcal infection.
- Carriers of Neisseria meningitides based on cultures from naso-pharyngeal swabs during screening.
- Subject has had a splenectomy.
- Known allergy to penicillin class antibiotics
- Known or suspected complement deficiency, or abnormal complement C3, C4 or CH50 during screening.
- Recent (within the previous 2 months) bacterial, protozoal, viral or parasite infection requiring systemic treatment.
- History of tuberculosis or systemic fungal diseases
- HIV infection or HIV seropositivity at the screening visit
- Positive HBsAg, HBcAb, or hepatitis C antibody at the screening visit
- History of malignancy (except non-melanoma skin cancer or cervical in-situ)
- Pregnant or breastfeeding women
- Women of childbearing potential and men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (Cohorts 1-4 & 6a) Placebo Cohorts 1-4 and 6a will receive placebo REGN3918 (Cohorts 1-4 & 6a) REGN3918 Cohorts 1-4 and 6a will receive sequential ascending doses of REGN3918 REGN3918 (Cohort 5 & 6b) REGN3918 Cohort 5 and 6b will receive multiple doses of REGN3918 Placebo (Cohort 5 & 6b) Placebo Cohort 5 and 6b will receive placebo
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAEs) Up to 20 weeks Severity of TEAEs Up to 20 weeks
- Secondary Outcome Measures
Name Time Method Pharmacodynamics profile of REGN3918 Up to 20 weeks Assessed by CH50 assay over time
Pharmacokinetic profile of REGN3918; single dose IV and SC Up to 20 weeks Assessed via serum concentrations of REGN3918 over time; Area under the Curve (AUC)
Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses Up to 20 weeks Assessed via serum concentrations of REGN3918 over time; peak concentration Cmax
Pharmacokinetic exploratory analysis Up to 20 weeks Peak concentration Cmax
Immunogenicity of REGN3918 Up to 20 weeks Assessed by measurement of anti-drug antibodies (ADA)
Trial Locations
- Locations (1)
Covance Clinical Research Unit (CRU) Ltd.
🇬🇧Leeds, United Kingdom