First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers

Overview

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

Full Title of Study: “A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2013

Interventions

  • Drug: NI-0501
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: NI-0501
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Safety and tolerability of escalating single IV doses of NI-0501.
    • Time Frame: AEs at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10, 12 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8

Secondary Measures

  • Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501
    • Time Frame: PK/PD at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8, Immunogenicity: SD1 pre-infusion, Wk 8

Participating in This Clinical Trial

Inclusion Criteria

  • healthy adults between 18 and 50 years old – non smokers – able to adhere to study protocol requirements Exclusion Criteria:

  • any abnormal clinical safety laboratory parameters

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Swedish Orphan Biovitrum
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Steve Warrington, MD, Principal Investigator, HMR
    • Peter Dewland, MD, Principal Investigator, ICON plc

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