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GS-6624

Phase 1

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Gilead Sciences, Inc.|Last Updated: Jul 9, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

GS-6624 · 1 trial · 1 indication

Phase 1 1
NCT01362231A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
113 days

To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).

Secondary Endpoints

- To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ
113 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
GS-6624 125mgEXPERIMENTAL -
Experimental: GS-6624 200mgEXPERIMENTAL -

Interventions

NameTypeDescription
GS-6624DRUGPatients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
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Eligibility Criteria

Age Range40 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Acceptable results on pulmonary function tests 2. At rest oxygen saturation ≥90% on room air 3. Adequate organ function Exclusion Criteria: 1. High resolution computer tomography pattern showing emphysema that is greater than fibrosis 2. Acceptable results on whole body ple...

Countries:United States
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Frequently asked questions about GS-6624

What is GS-6624 used for?

GS-6624 is an investigational small molecule being studied for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and progressive lung disease. It is currently in Phase 1 clinical development and is not yet approved for any use.

Who makes GS-6624?

GS-6624 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 1 clinical development for idiopathic pulmonary fibrosis.

What phase is GS-6624 in?

GS-6624 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under investigation for idiopathic pulmonary fibrosis.

What clinical trials is GS-6624 in?

GS-6624 has one completed clinical trial, NCT01362231, which evaluated the safety and efficacy of the drug in patients with idiopathic pulmonary fibrosis. The trial enrolled 48 participants in the United States and was a controlled, randomized study.

Is GS-6624 the same as AB0024?

Yes, GS-6624 was formerly known as AB0024. The clinical trial NCT01362231, which studied the drug in idiopathic pulmonary fibrosis, refers to GS-6624 as AB0024 in its title, indicating the name change.