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

NCT ID: NCT01459562

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NI-0501

Group Type EXPERIMENTAL

NI-0501

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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NI-0501

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Warrington, MD

Role: PRINCIPAL_INVESTIGATOR

HMR

Peter Dewland, MD

Role: PRINCIPAL_INVESTIGATOR

ICON plc

Locations

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HMR

London, , United Kingdom

Site Status

ICON

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NI-0501-03

Identifier Type: -

Identifier Source: org_study_id

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