NCT03115996

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2017

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

April 5, 2017

Last Update Submit

September 25, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Incidence of treatment emergent adverse events (TEAEs)

    Up to 20 weeks

  • Severity of TEAEs

    Up to 20 weeks

Secondary Outcomes (5)

  • Pharmacokinetic profile of REGN3918; single dose IV and SC

    Up to 20 weeks

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

    Up to 20 weeks

  • Pharmacodynamics profile of REGN3918

    Up to 20 weeks

  • Pharmacokinetic exploratory analysis

    Up to 20 weeks

  • Immunogenicity of REGN3918

    Up to 20 weeks

Study Arms (4)

REGN3918 (Cohorts 1-4 & 6a)

EXPERIMENTAL

Cohorts 1-4 and 6a will receive sequential ascending doses of REGN3918

Drug: REGN3918

Placebo (Cohorts 1-4 & 6a)

EXPERIMENTAL

Cohorts 1-4 and 6a will receive placebo

Drug: Placebo

REGN3918 (Cohort 5 & 6b)

EXPERIMENTAL

Cohort 5 and 6b will receive multiple doses of REGN3918

Drug: REGN3918

Placebo (Cohort 5 & 6b)

EXPERIMENTAL

Cohort 5 and 6b will receive placebo

Drug: Placebo

Interventions

REGN3918DRUG

Intravenous (IV) or Subcutaneous (SC)

REGN3918 (Cohort 5 & 6b)REGN3918 (Cohorts 1-4 & 6a)
PlaceboDRUG

Matching Placebo

Placebo (Cohort 5 & 6b)Placebo (Cohorts 1-4 & 6a)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

Location

Related Publications (1)

  • Devalaraja-Narashimha K, Ehmann PJ, Huang C, Ruan Q, Wipperman MF, Kaplan T, Liu C, Afolayan S, Glass DJ, Mellis S, Yancopoulos GD, Hamilton JD, MacDonnell S, Hamon SC, Boyapati A, Morton L. Association of complement pathways with COVID-19 severity and outcomes. Microbes Infect. 2023 May;25(4):105081. doi: 10.1016/j.micinf.2022.105081. Epub 2022 Dec 7.

    PMID: 36494054DERIVED

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 14, 2017

Study Start

May 10, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

GB(1)