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GS-6624

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01362231A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary FibrosisPHASE1 COMPLETED 48Dec 1, 2010Dec 1, 2012Jul 9, 20157 United States
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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 — 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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