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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