NCT03473236

Phase 1A Safety Trial of Inhaled PK10571 (GB002)

A Phase 1A Single Ascending Dose and Multiple Ascending Dose Double-Blind, Placebo-Controlled, Randomized Trial of Oral Inhalation PK10571 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, two-part study in healthy adult males and females of non-childbearing potential. "Double-Blind" means neither the study subject nor the investigator knows if PK10571 or placebo is being given. "Placebo" means a capsule filled with a powder that does not contain the active drug, PK10571. Because the safety profile of PK10571 in humans is unknown and this is the first clinical study to assess PK10571 in humans, a single-ascending dose design will be used in Part A of the study going from a low dose to higher doses based on safety. Part B will be a multiple-ascending dose design to be run only after review of safety and measurement of drug levels in the blood from Part A. In the single ascending dose study (Part A) up to five doses may be given to different groups of study subjects based on safety and measurement of drug levels in the blood. Subjects will be randomized into one dose cohort to receive either PK10571 or placebo. Within each cohort, 6 subjects will receive active drug and 2 subjects will receive placebo. In the multiple ascending dose study (Part B), up to three doses of PK10571 will be tested. The daily dose will be administered daily for 7 days with close clinical monitoring. The dose for the first cohort of Part B will be determined by review of the safety and drug levels from Part A by the Safety Review Committee. The dose interval for the first cohort of Part B (i.e., once daily, twice daily, or up to three times daily) will be determined by review of the safety and drug levels in the blood from Part A by the Safety Review committee. Subsequent doses and dosing intervals will be determined by review of the safety and drug levels from the prior cohort.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	GB002	Inhaled GB002
DEVICE	Generic Dry Powder Inhaler	dry powder inhaler used for inhalation of active drug or placebo
DRUG	Placebo	Inhaled placebo

Timeline

• Start date: 2017-09-06
• Primary completion: 2018-12-03
• Completion: 2018-12-03
• First posted: 2018-03-22
• Last updated: 2020-06-09
• Results posted: 2020-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study