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Phase 1A Safety Trial of Inhaled PK10571 (GB002)

NCT03473236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-06-09

Study results available
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Summary

This is a phase 1A randomized double blind placebo controlled single ascending dose and multiple ascending dose trial of inhaled PK10571 (GB002) in healthy adult subjects.

Conditions

  • Safety Issues

Interventions

DRUG

GB002

Inhaled GB002

DEVICE

Generic Dry Powder Inhaler

dry powder inhaler used for inhalation of active drug or placebo

DRUG

Placebo

Inhaled placebo

Sponsors & Collaborators

  • Pulmokine Inc.

    collaborator INDUSTRY

  • Worldwide Clinical Trials

    collaborator OTHER

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2018-12-03
Completion
2018-12-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03473236 on ClinicalTrials.gov