Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115996
• Other study ID #: R3918-HV-1659
• Secondary ID: 2016-004208-70
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.

Description:

Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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/Exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN3918
Intravenous (IV) or Subcutaneous (SC)
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit (CRU) Ltd.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events (TEAEs)		Up to 20 weeks
Primary	Severity of TEAEs		Up to 20 weeks
Secondary	Pharmacokinetic profile of REGN3918; single dose IV and SC	Assessed via serum concentrations of REGN3918 over time; Area under the Curve (AUC)	Up to 20 weeks
Secondary	Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses	Assessed via serum concentrations of REGN3918 over time; peak concentration Cmax	Up to 20 weeks
Secondary	Pharmacodynamics profile of REGN3918	Assessed by CH50 assay over time	Up to 20 weeks
Secondary	Pharmacokinetic exploratory analysis	Peak concentration Cmax	Up to 20 weeks
Secondary	Immunogenicity of REGN3918	Assessed by measurement of anti-drug antibodies (ADA)	Up to 20 weeks