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Safety, Tolerability, and Pharmacokinetics of PA9159 Nasal Spray in Healthy Adult Subjects

NCT05170763 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-19

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 intranasal PA9159, to establish maximum tolerated dose in healthy chinese adult

Conditions

  • Allergic Rhinitis

Interventions

DRUG

PA9159 nasal spray solution, 10 μg one day treatment

Single dose of PA9159 (5 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, one spray each in the left and right nostril.

DRUG

PA9159 nasal spray solution, 20 μg one day treatment

Single dose of PA9159 (5 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.

DRUG

PA9159 nasal spray solution, 40 μg one day treatment

Single dose of PA9159 (10 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.

DRUG

PA9159 nasal spray solution, 80 μg one day treatment

Single dose of PA9159 (10 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, four sprays each in the left and right nostril.

DRUG

PA9159 nasal spray solution, 20 μg 7-day treatment

Repeated doses of PA9159 (5 μg/nasal spray) or Placebo is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.

DRUG

PA9159 nasal spray solution, 40 μg 7-day treatment

Repeated doses of PA9159 (10 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.

DRUG

Placebo, the same intranasal spray solution without PA9159 active ingredient

Placebo is delivered intranasally through a metered-dose mechanical spray pump with the same volume as the corresponding PA9159 dose group

Sponsors & Collaborators

  • Anhui Palo Alto Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Luo Zhang · Beijing Tongren Hospital

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
2021-11-10
Primary Completion
2022-01-05
Completion
2022-01-05

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 NCT05170763 on ClinicalTrials.gov