Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind,
placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with
Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.
Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in
subjects with IPF and is currently enrolling.
The primary objective of this study is to characterize the safety, tolerability, and PK of
GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are
to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624
on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind
phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed
in October 2011.
In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is
currently enrolling.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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