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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: NI-0501; Drug: Placebo

• Registration Number: NCT01459562
• Lead Sponsor: Swedish Orphan Biovitrum

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-17
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NI-0501	NI-0501	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of escalating single IV doses of NI-0501.	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 Outcome Measures

Name	Time	Method
Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501	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

Trial Locations

Locations (2)

HMR; 🇬🇧 London, United Kingdom

ICON; 🇬🇧 Manchester, United Kingdom