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

NCT06916273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-30

No results posted yet for this study

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

Conditions

  • Bronchial Asthma

Interventions

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

Sponsors & Collaborators

  • Anhui Palo Alto Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jinhua Wen, phD · The First Affiliated Hospital of Nanchang University

  • Xiaohua Cheng, Master · The First Affiliated Hospital of Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2024-09-12
Completion
2024-09-21

Countries

  • China

Study Locations

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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 NCT06916273 on ClinicalTrials.gov