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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 10, 2021

Primary Completion Date

January 5, 2022

Study Completion Date

January 5, 2022

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

Trial Locations (1)

Unknown

Beijing TongRen Hospital, Beijing

All Listed Sponsors
lead

Anhui Palo Alto Pharmaceuticals, Inc.

INDUSTRY