Safety, Tolerability, and Pharmacokinetics of PA9159 Nasal Spray in Healthy Adult Subjects
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): PA9159 nasal spray solution, 10 μg one day treatment; PA9159 nasal spray solution, 20 μg one day treatment; PA9159 nasal spray solution, 40 μg one day treatment; PA9159 nasal spray solution, 80 μg one day treatment; PA9159 nasal spray solution, 20 μg 7-day treatment; PA9159 nasal spray solution, 40 μg 7-day treatment; Placebo, the same intranasal spray solution without PA9159 active ingredient
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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.; 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.; 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.; Placebo is delivered intranasally through a metered-dose mechanical spray pump with the same volume as the corresponding PA9159 dose group
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Arm 1-4, the treatment is given once for one day, with escalation doses of 10 μg, 20 μg, 40 μg, 80 μg. Arm 5-6, 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment