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

NCT03926793 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-09-01

No results posted yet for this study

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).

Conditions

Interventions

DRUG

GB002

GB002 low dose or high dose for inhalation

DRUG

Placebo

Placebo for inhalation

DEVICE

Generic Dry Powder Inhaler

Generic dry powder inhaler for GB002 or Placebo delivery

Sponsors & Collaborators

  • GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2021-05-05
Completion
2021-05-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03926793 on ClinicalTrials.gov