Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
PAH
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)
1 other identifier
interventional
8
2 countries
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2020
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2019
CompletedFirst Posted
Study publicly available on registry
April 25, 2019
CompletedStudy Start
First participant enrolled
February 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2021
CompletedSeptember 1, 2021
August 1, 2021
1.2 years
April 22, 2019
August 30, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with Treatment-Related Adverse Events GB002 (Main study)
To evaluate the safety and tolerability of GB002
Up to 45 days
Number of participants with Treatment-Related Adverse Events GB002 (OLE study)
To evaluate the long-term safety and tolerability and efficacy of GB002
Up to 200 days
Secondary Outcomes (8)
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB002 (Main study)
14 days
Pharmacokinetics: Maximum Concentration (Cmax) of GB002 (Main study)
14 days
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB002 (Main study)
14 days
Changes from baseline in 6-Minute Walk Test (6MWT) (OLE study)
169 days
Changes from baseline in WHO Functional Class (OLE study)
197 days
- +3 more secondary outcomes
Study Arms (3)
Cohort 1
EXPERIMENTALPatients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
Cohort 2
EXPERIMENTALPatients will be randomized to receive inhaled GB002 or Placebo daily for 14 days
Open Label Extension
EXPERIMENTALEligible subjects may participate in the Open Label Extension (OLE) study for a period of 24 weeks.
Interventions
Generic dry powder inhaler for GB002 or Placebo delivery
Eligibility Criteria
You may qualify if:
- Adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH) (Main study)
- A current diagnosis of symptomatic PAH classified by one of the following (Main and OLE study):
- Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)
- PAH associated with one of the following connective tissue diseases (CTDs):
- systemic sclerosis, rheumatoid arthritis, mixed CTD or overlap syndrome, or systemic lupus erythematosus
- PAH associated with anorexigen or methamphetamine use
- World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology (Main study)
You may not qualify if:
- Clinically significant systemic hypertension or hypotension (Main and OLE study)
- History of left-sided heart disease and/or clinically significant cardiac disease (Main and OLE study)
- History of decompensated right heart failure within 30 days of screening (e.g., hospitalization for PAH or the need to add an additional PAH medication) (Main study)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
UCSD Medical Center
La Jolla, California, 92037, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Duke Early Phase Research
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pittsburgh Medical Center Montefiore University Hospital
Pittsburgh, Pennsylvania, 15213, United States
VitaLink Research - Anderson
Anderson, South Carolina, 29621, United States
Golden Jubilee National Hospital
Glasgow, G814DY, United Kingdom
Hammersmith Hospital, Imperial Healthcare NHS Trust
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Clinical site investigators, study personnel, and study subjects will be blinded to treatment assignment; however, the Sponsor will be unblinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2019
First Posted
April 25, 2019
Study Start
February 4, 2020
Primary Completion
May 5, 2021
Study Completion
May 5, 2021
Last Updated
September 1, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share