Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2021-05-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GB002, Inc.; GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Criteria

Inclusion Criteria:

1. Adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH) (Main study)

2. A current diagnosis of symptomatic PAH classified by one of the following (Main and OLE study):

1. Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)

2. PAH associated with one of the following connective tissue diseases (CTDs):

systemic sclerosis, rheumatoid arthritis, mixed CTD or overlap syndrome, or systemic lupus erythematosus

3. PAH associated with anorexigen or methamphetamine use

3. World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology (Main study)

Exclusion Criteria:

1. Clinically significant systemic hypertension or hypotension (Main and OLE study)

2. History of left-sided heart disease and/or clinically significant cardiac disease (Main and OLE study)

3. 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)

NOTE: Additional inclusion/exclusion criteria may apply, per protocol.