NCT05170763

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

A Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics of Single Dose and 7-day Repeat Doses of PA9159 Nasal Spray in Healthy Chinese Adult

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (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 intranasal 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 nasal spray. In the first part of the study, the treatment is given once for one day, with escalation doses of 10 μg, 20 μg, 40 μg, 80 μg. In the second part of the study, PA9159 at the escalation dose of 20 μg and 40 μg is given once a day for 7 days. 10 health subjects will be enrolled for each dose group, randomized proportionally at 4:1 ratio to receive either the investigational product PA9159 or placebo nasal spray, with a total of 60 subjects for this two-part study. Subjects will be evaluated for the safety, tolerability and pharmacokinetics of PA9159 intranasal spray.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-01-05
• Completion: 2022-01-05
• First posted: 2021-12-28
• Last updated: 2022-01-19

Locations

1 site across 1 country: China