NCT06916273

Safety, Tolerability, and Pharmacokinetics of PA9159 Inhalation Aerosol in Healthy Adult Subjects

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of PA9159 Inhalation Aerosol in Healthy Adult Subjects in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Anhui Palo Alto Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

PA9159 is a highly potent novel corticosteroid. The purpose of this study is to exam the safety, tolerability, and pharmacokinetics of single and repeat dosing of Inhalation aerosol PA9159, to establish maximum tolerated dose in healthy chinese adult

Detailed description

This is a randomized, double-blind, placebo-controlled dose escalation phase 1 trial, including single dose and 7-day repeat doses of PA9159 Inhalation aerosol. In the first part of the study, the treatment is given once for one day, with escalation doses of 60 μg, 120 μg, 240 μg, 300 μg. 30 health subjects will be enrolled for this part. In the second part of the study, PA9159 at the escalation dose of 120 μg is given twice a day for 7 days. 10 health subjects will be enrolled for this group, randomized proportionally at 4:1 ratio to receive either the investigational product PA9159 Inhalation aerosol or placebo , with a total of 40 subjects for this two-part study. Subjects will be evaluated for the safety, tolerability and pharmacokinetics of PA9159 Inhalation aerosol.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	PA9159 Inhalation aerosol, 60 μg one day treatment	single dose of PA9159 (60 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 2 puffs.
DRUG	PA9159 Inhalation aerosol, 120 μg one day treatment	single dose of PA9159 (120 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 4 puffs.
DRUG	PA9159 Inhalation aerosol, 240 μg one day treatment	single dose of PA9159 (240 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 8 puffs.
DRUG	PA9159 Inhalation aerosol, 300 μg one day treatment	single dose of PA9159 (300 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 10 puffs.
DRUG	PA9159 Inhalation aerosol, 120 μg 7-day treatment	Repeated doses of PA9159 (120 μg/inhaler spray) i is administered by inhalation through an inhaler via the mouth, with 4 puffs, twice a day.
DRUG	Placebo, the same Inhalation aerosol solution without PA9159 active ingredient	Placebo is delivered via the mouth through an inhaler with the same volume as the corresponding PA9159 dose group

Timeline

• Start date: 2024-07-22
• Primary completion: 2024-09-12
• Completion: 2024-09-21
• First posted: 2025-04-08
• Last updated: 2025-12-30

Locations

1 site across 1 country: China