Healthy Volunteers
Conditions
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.
Interventions
DRUGREGN3918
Intravenous (IV) or Subcutaneous (SC)
DRUGPlacebo
Matching Placebo
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: A subject must meet the follow criteria to be eligible for inclusion in the study: 1. Males and females from 18 to 50 years of age. 2. 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 3. The subject has a body mass index less than 30 kg/m2 4. Willingness to undergo vaccination and antibiotic prophylaxis against N. meningitides. Key
Exclusion criteria
A subject who meets any of the following criteria will be excluded from the study: 1. Any clinically significant physical examination abnormalities observed during the screening visit. 2. Hospitalization for any reason within 30 days of the screening visit 3. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals. 4. Subject has a history of meningococcal infection. 5. Carriers of Neisseria meningitides based on cultures from naso-pharyngeal swabs during screening. 6. Subject has had a splenectomy. 7. Known allergy to penicillin class antibiotics 8. Known or suspected complement deficiency, or abnormal complement C3, C4 or CH50 during screening. 9. Recent (within the previous 2 months) bacterial, protozoal, viral or parasite infection requiring systemic treatment. 10. History of tuberculosis or systemic fungal diseases 11. HIV infection or HIV seropositivity at the screening visit 12. Positive HBsAg, HBcAb, or hepatitis C antibody at the screening visit 13. History of malignancy (except non-melanoma skin cancer or cervical in-situ) 14. Pregnant or breastfeeding women 15. 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | Up to 20 weeks |
| Severity of TEAEs | Up to 20 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Immunogenicity of REGN3918 | Up to 20 weeks | Assessed by measurement of anti-drug antibodies (ADA) |
| Pharmacokinetic exploratory analysis | Up to 20 weeks | Peak concentration Cmax |
| 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 |
Countries
United Kingdom
Outcome results
None listed