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

Sobi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: NI-0501; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01459562

NI-0501-03

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

NI-0501

Experimental group

Treatment:

Drug: NI-0501

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo