Allergic RhinitisPhase 1NCT07345442
Study on the Safety, Tolerability, and Pharmacokinetics of PA9159 Nasal Spray in Healthy Adult Subjects
A Phase 1 study testing PA9159 nasal spray solution, 80 μg one day treatment, PA9159 nasal spray solution, 160 μg one day treatment and PA9159 nasal spray solution, 320 μg one day treatment in people with Allergic Rhinitis, run by Anhui Palo Alto Pharmaceuticals, Inc. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- PA9159 nasal spray solution, 80 μg one day treatment, PA9159 nasal spray solution, 160 μg one day treatment and PA9159 nasal spray solution, 320 μg one day treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2025to 9 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 to 65 years (including upper and lower limits);
- Male body weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 26 kg/m2 (including cut-off values);
- Voluntary participation and signing of informed consent.
Who cannot join
- Those who cannot properly use a nasal spray, cannot tolerate nasal administration, or fail nasal spray administration training;
- Those with special dietary requirements who cannot adhere to a standard diet;
- Those with a history of serious diseases affecting the respiratory, cardiovascular, digestive, endocrine, hematologic, immune, or nervous systems, or currently suffering from diseases of the aforementioned systems;
- A history of recurrent (defined as more than once) or disseminated shingles, glaucoma, cataracts, or ocular infectious diseases;
- Allergic to the investigational drug or any component of the investigational drug, or having an allergic constitution (referring to being allergic to two or more foods, drugs, or environmental substances);
- Vital signs during the screening period, physical examination, nasal examination, laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function), serum cortisol, chest X-ray, abdominal ultrasound, 12-lead electrocardiogram, and other abnormalities judged by the investigator to be clinically significant;
Show all 20Show fewer
- Those who test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), syphilis treponemal antibody (Syphilis TP), or HIV (HIV Ag/Ab);
- Exclude individuals who have frequently consumed alcohol in the past three months, defined as drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol, 45 mL of spirits with 40% alcohol, or 150 mL of wine with 12% alcohol), or those who tested positive on baseline breath alcohol tests, or those unable to stop alcohol intake during the study period;
- Those with a smoking history of more than 10 years, or who smoke more than 5 cigarettes per day in the 3 months prior to screening, or who cannot stop using any tobacco products during the trial, or who test positive for nicotine at baseline;
- Individuals with a history of drug abuse or drug use in the past two years, or those who tested positive for drug use in baseline urine screening;
- Individuals who have taken any medication (prescription drugs, over-the-counter drugs, Chinese herbal medicine, vaccines) or health supplements within the 2 weeks prior to screening or during the screening period;
- Exclude individuals who have used preparations containing corticosteroids or any drugs affecting CYP3A4 enzyme activity within the 30 days prior to screening or during the screening period;
- Participants who have consumed beverages or foods containing grapefruit, dragon fruit, mango, pomelo, pomegranate, papaya, or star fruit within 14 days prior to screening and during the screening period, or who do not agree to stop consuming the above foods during the trial;
- Anyone who consumes any foods or beverages rich in caffeine or methylxanthines (such as coffee, tea, cola, chocolate, seafood, cocoa, animal liver, etc.) within 48 hours prior to the first use of the investigational drug, or who does not agree to stop consuming the above foods during the trial;
- Individuals who have donated blood or experienced significant blood loss (≥400 mL) within the 90 days prior to screening, or who have used blood products or received a transfusion;
- Participants who have taken part in other clinical studies and used study products within the 90 days prior to screening;
- Individuals who have previously undergone respiratory system surgery, have had major surgery within the three months prior to screening (as determined by the investigator based on past medical history), have experienced major trauma, or plan to undergo surgery during the study period;
- Difficulty with venous blood collection, or a known history of fainting at the sight of needles or blood;
- Women who test positive for pregnancy or are breastfeeding;
- Researchers believe there are other situations in which participation in the trial is not suitable, or the subject cannot participate in the trial due to personal reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
About this study
Official title: 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
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
Read the 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 study, the treatment is given once for one day, with escalation doses of 80 μg, 160 μg, 320 μg. After two days elution, PA9159 at the escalation dose of 80 μg, 160 μg, 320 μg is given once a day for 7 days. 12 health subjects will be enrolled for each dose group, randomized proportionally at 3:1 ratio to receive either the investigational product PA9159 or placebo nasal spray, with a total of 36 subjects for this two-part study. Subjects will be evaluated for the safety, tolerability and pharmacokinetics of PA9159 intranasal spray.
- Conditions
- Allergic Rhinitis
- Being tested
- PA9159 nasal spray solution, 80 μg one day treatment, PA9159 nasal spray solution, 160 μg one day treatment, PA9159 nasal spray solution, 320 μg one day treatment, PA9159 nasal spray solution, 80 μg 7-day treatment, PA9159 nasal spray solution, 160 μg 7-day treatment
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA9159 nasal spray solution, 80 μg one day treatmentDrug
Single dose of PA9159 (20 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.nostril.
PA9159 nasal spray solution, 160 μg one day treatmentDrug
Single dose of PA9159 (40 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.
PA9159 nasal spray solution, 320 μg one day treatmentDrug
Single dose of PA9159 (80 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.
PA9159 nasal spray solution, 80 μg 7-day treatmentDrug
Repeated doses of PA9159 (20 μg/nasal spray) or Placebo is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.
PA9159 nasal spray solution, 160 μg 7-day treatmentDrug
Repeated doses of PA9159 (40 μg/nasal spray) or Placebo is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.
PA9159 nasal spray solution, 320 μg 7-day treatmentDrug
Repeated doses of PA9159 (80 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.
Placebo, the same intranasal spray solution without PA9159 active ingredientDrug
Placebo is delivered intranasally through a metered-dose mechanical spray pump with the same volume as the corresponding PA9159 dose group
| Study group | Role | What they receive |
|---|---|---|
| PA9159 80 μg single dose and placebo | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either single dose of 80 μg PA9159 or placebo. There will be a follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 80 μg one day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 160 μg single dose and placebo | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either single dose of 160 μg PA9159 or placebo. There will be a follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 160 μg one day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 320 μg single dose and placebo | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either single dose of 320 μg PA9159 or placebo. There will be a follow-up period to review all available clinical and laboratory safety data. Receives: Drug: PA9159 nasal spray solution, 320 μg one day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 80 μg repeated doses and placebo | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 80 μg PA9159 or placebo once a day for 7 days. There will be follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 80 μg 7-day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 160 μg repeated doses and placebo | Experimental | Twelve Ten subjects will be randomly assigned at a 3: 1 ratio to receive either 160 μg PA9159 or placebo once a day for 7 days. There will be follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 160 μg 7-day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 320 μg repeated doses and placebo | Experimental | Twelve subjects will be randomly assigned at a 3: 1 ratio to receive either 320 μg PA9159 or placebo once a day for 7 days. There will be a follow-up period to review all available clinical and laboratory safety data. Receives: Drug: PA9159 nasal spray solution, 320 μg 7-day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Measured: up to 7 days after last nasal spray treatment
Secondary outcomes (4)
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-Cmax
Blood samples will be collected serially, and the concentrations of PA9159 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-Tmax
Blood samples will be collected serially, and the concentrations of PA9159 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-AUC
Blood samples will be collected serially, and the concentrations of PA9159 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Area Under the Plasma Concentration-Time Curve (AUC)
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-T1/2
Blood samples will be collected serially, and the concentrations of PA9159 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Elimination Half-Life Period (T1/2)
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start14 Mar 2025
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Arm 1-3, the treatment is given once for one day, with escalation doses of 80 μg, 160 μg, 320 μg, After two days elution, Arm 4-6, at the escalation dose of 80 μg, 160 μg, 320 μg is given once a day for 7 days. 12 health subjects will be enrolled for each dose group, randomized proportionally at 3:1 ratio to receive either the investigational product PA9159 or placebo nasal spray, with a total of 36 subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinhua Wen, Principal investigator, The First Affiliated Hospital of Nanchang UniversityXiaohua Cheng, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345442
- Sponsor's protocol ID
- PA9159-102
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07345442
- Acronym / sponsor ID
- PA9159-102
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study, the treatment is given once for one day, with escalation doses of 80 μg, 160 μg, 320 μg. After two days elution, PA9159 at the escalation dose of 80 μg, 160 μg, 320 μg is given once a day for 7 days. 12 health subjects will be enrolled for each dose group, randomized proportionally at 3:1 ratio to receive either the investigational product PA9159 or placebo nasal spray, with a total of 36 subjects for this two-part study. Subjects will be evaluated for the safety, tolerability and pharmacokinetics of PA9159 intranasal spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Arm 1-3, the treatment is given once for one day, with escalation doses of 80 μg, 160 μg, 320 μg, After two days elution, Arm 4-6, at the escalation dose of 80 μg, 160 μg, 320 μg is given once a day for 7 days. 12 health subjects will be enrolled for each dose group, randomized proportionally at 3:1 ratio to receive either the investigational product PA9159 or placebo nasal spray, with a total of 36 subjects.
| Arm | Type | Receives |
|---|---|---|
| PA9159 80 μg single dose and placebo | Experimental | Drug: PA9159 nasal spray solution, 80 μg one day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTwelve subjects will be randomly assigned at a 3: 1 ratio to receive either single dose of 80 μg PA9159 or placebo. There will be a follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| PA9159 160 μg single dose and placebo | Experimental | Drug: PA9159 nasal spray solution, 160 μg one day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTwelve subjects will be randomly assigned at a 3: 1 ratio to receive either single dose of 160 μg PA9159 or placebo. There will be a follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| PA9159 320 μg single dose and placebo | Experimental | Drug: PA9159 nasal spray solution, 320 μg one day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTwelve subjects will be randomly assigned at a 3: 1 ratio to receive either single dose of 320 μg PA9159 or placebo. There will be a follow-up period to review all available clinical and laboratory safety data. |
| PA9159 80 μg repeated doses and placebo | Experimental | Drug: PA9159 nasal spray solution, 80 μg 7-day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTwelve subjects will be randomly assigned at a 3: 1 ratio to receive either 80 μg PA9159 or placebo once a day for 7 days. There will be follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| PA9159 160 μg repeated doses and placebo | Experimental | Drug: PA9159 nasal spray solution, 160 μg 7-day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTwelve Ten subjects will be randomly assigned at a 3: 1 ratio to receive either 160 μg PA9159 or placebo once a day for 7 days. There will be follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| PA9159 320 μg repeated doses and placebo | Experimental | Drug: PA9159 nasal spray solution, 320 μg 7-day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTwelve subjects will be randomly assigned at a 3: 1 ratio to receive either 320 μg PA9159 or placebo once a day for 7 days. There will be a follow-up period to review all available clinical and laboratory safety data. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects aged 18 to 65 years (including upper and lower limits);
- Male body weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 26 kg/m2 (including cut-off values);
- Voluntary participation and signing of informed consent.
Key exclusion criteria (20 listed)
- Those who cannot properly use a nasal spray, cannot tolerate nasal administration, or fail nasal spray administration training;
- Those with special dietary requirements who cannot adhere to a standard diet;
- Those with a history of serious diseases affecting the respiratory, cardiovascular, digestive, endocrine, hematologic, immune, or nervous systems, or currently suffering from diseases of the aforementioned systems;
- A history of recurrent (defined as more than once) or disseminated shingles, glaucoma, cataracts, or ocular infectious diseases;
- Allergic to the investigational drug or any component of the investigational drug, or having an allergic constitution (referring to being allergic to two or more foods, drugs, or environmental substances);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA9159 nasal spray solution, 80 μg one day treatmentSingle dose of PA9159 (20 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril.nostril. | Drug | PA9159 80 μg single dose and placebo |
| PA9159 nasal spray solution, 160 μg one day treatmentSingle dose of PA9159 (40 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril. | Drug | PA9159 160 μg single dose and placebo |
| PA9159 nasal spray solution, 320 μg one day treatmentSingle dose of PA9159 (80 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril. | Drug | PA9159 320 μg single dose and placebo |
| PA9159 nasal spray solution, 80 μg 7-day treatmentRepeated doses of PA9159 (20 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 80 μg repeated doses and placebo |
| PA9159 nasal spray solution, 160 μg 7-day treatmentRepeated doses of PA9159 (40 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 160 μg repeated doses and placebo |
| PA9159 nasal spray solution, 320 μg 7-day treatmentRepeated doses of PA9159 (80 μg/nasal spray) is delivered intranasally through a metered-dose mechanical spray pump, two sprays each in the left and right nostril. | Drug | PA9159 320 μg repeated doses and placebo |
| Placebo, the same intranasal spray solution without PA9159 active ingredientPlacebo is delivered intranasally through a metered-dose mechanical spray pump with the same volume as the corresponding PA9159 dose group | Drug | PA9159 160 μg repeated doses and placebo, PA9159 160 μg single dose and placebo, PA9159 320 μg repeated doses and placebo, PA9159 320 μg single dose and placebo, PA9159 80 μg repeated doses and placebo, PA9159 80 μg single dose and placebo |
Primary outcome
Number of subjects experiencing adverse events (AEs)
Time frame: up to 7 days after last nasal spray treatment
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
4 secondary outcomes
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-Cmax
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-Tmax
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-AUC
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Pharmacokinetics of single dose and repeat doses of Nasal Spray PA9159-T1/2
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects) 0.5, 1, 1, 2, 4, 6, 8, 12,12, 24 hours, and for repeat doses subjects, also 30 minutes pre-dose on day 4, day 5 and day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinhua Wen principal investigator
The First Affiliated Hospital of Nanchang University
Xiaohua Cheng principal investigator
The First Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PA9159 nasal spray solution, 80 μg one day treatment, PA9159 nasal spray solution, 160 μg one day treatment and PA9159 nasal spray solution, 320 μg one day treatment in people with Allergic Rhinitis, run by Anhui Palo Alto Pharmaceuticals, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing adverse events (AEs) (time frame: up to 7 days after last nasal spray treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.