Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03926793
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2019-04-22
Brief Title:
Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
Sponsor:
GB002 Inc a wholly owned subsidiary of Gossamer Bio Inc
Organization:
Gossamer Bio Inc
Study Overview
Official Title:
A Phase 1b Randomized Subject- and Investigator-Blinded Placebo-Controlled Multi-Center Clinical Trial to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAH
Brief Summary:
This is a Phase 1B randomized participant- and investigator-blinded placebo-controlled multi-center clinical trial to evaluate the safety pharmacokinetics PK pharmacodynamics PD and biomarkers of inhaled GB002 in adults with World Health Organization WHO Group 1 Pulmonary Arterial Hypertension PAH
Detailed Description:
The primary objective for this trial is to evaluate the safety and tolerability of GB002 The secondary objective for this trial is to evaluate the PK parameters of GB002 Exploratory objectives are to evaluate the PD readouts change in WHO Group I functional class and change in quality of life associated with GB002 treatment
In this Phase 1B study two dose levels of GB002 will be tested in adult participants with PAH Four participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo with 3 subjects receiving GB002 and 1 subject receiving placebo An additional 4 participants 3 active and 1 placebo may be added to cohort 1 at the discretion of the Data Review Committee DRC The dose and dosing interval ie once daily or twice daily for the second cohort will be determined by review of the safety tolerability and drug levels in the blood from cohort 1 Cohort 2 participants will also be randomized such that 6 subjects receive GB002 and 2 subjects receive placebo
Eligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension
In this Phase 1B study two dose levels of GB002 will be tested in adult participants with PAH Four participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo with 3 subjects receiving GB002 and 1 subject receiving placebo An additional 4 participants 3 active and 1 placebo may be added to cohort 1 at the discretion of the Data Review Committee DRC The dose and dosing interval ie once daily or twice daily for the second cohort will be determined by review of the safety tolerability and drug levels in the blood from cohort 1 Cohort 2 participants will also be randomized such that 6 subjects receive GB002 and 2 subjects receive placebo
Eligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None