Summary

for people ages 18-75 (full criteria)
at UCSD
study started
estimated completion

Description

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).

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)

Details

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 and biomarkers 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. Participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo, with 6 subjects receiving GB002 and 2 subjects receiving placebo. The dose and dosing interval (i.e., once daily, twice daily, or up to three times 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.

Keywords

Pulmonary Arterial Hypertension Hypertension Familial Primary Pulmonary Hypertension Generic Dry Powder Inhaler

Eligibility

You can join if…

Open to people ages 18-75

  1. Adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH)
  2. A current diagnosis of symptomatic PAH classified by one of the following:
  3. Idiopathic (IPAH) or heritable pulmonary arterial hypertension (HPAH)
  4. PAH associated with one of the following connective tissue diseases (CTDs): limited scleroderma, mixed connective tissue disease or overlap syndrome, or systemic lupus erythematosus
  5. PAH associated with anorexigen or methamphetamine use
  6. World Health Organization (WHO)/New York Heart Association (NYHA) functional class II-IV symptomatology

You CAN'T join if...

  1. Clinically significant systemic hypertension or hypotension
  2. History of left-sided heart disease and/or clinically significant cardiac disease
  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)

Locations

  • UCSD not yet accepting patients
    La Jolla California 92037 United States
  • University of Colorado Denver accepting new patients
    Denver Colorado 80204 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GB002, Inc.
ID
NCT03926793
Phase
Phase 1
Study Type
Interventional
Last Updated