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OpenTrials
Completed

NCT Number: NCT03115996

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

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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 Exclusion Criteria:

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

Treatment and study plan

REGN3918

Drug

Intravenous (IV) or Subcutaneous (SC)

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame: Up to 20 weeks

  2. Severity of TEAEs

    Time frame: Up to 20 weeks

Secondary outcomes

  1. Pharmacokinetic profile of REGN3918; single dose IV and SC

    Time frame: Up to 20 weeks

    Assessed via serum concentrations of REGN3918 over time; Area under the Curve (AUC)

  2. Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses

    Time frame: Up to 20 weeks

    Assessed via serum concentrations of REGN3918 over time; peak concentration Cmax

  3. Pharmacodynamics profile of REGN3918

    Time frame: Up to 20 weeks

    Assessed by CH50 assay over time

  4. Pharmacokinetic exploratory analysis

    Time frame: Up to 20 weeks

    Peak concentration Cmax

  5. Immunogenicity of REGN3918

    Time frame: Up to 20 weeks

    Assessed by measurement of anti-drug antibodies (ADA)

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2017
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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