Bronchial AsthmaPhase 1NCT06916273
Safety, Tolerability, and Pharmacokinetics of PA9159 Inhalation Aerosol in Healthy Adult Subjects
A Phase 1 study testing PA9159 Inhalation aerosol, 60 μg one day treatment, PA9159 Inhalation aerosol, 120 μg one day treatment and PA9159 Inhalation aerosol, 240 μg one day treatment in people with Bronchial Asthma, 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 Inhalation aerosol 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
- Bronchial Asthma
- What is being tested?
- PA9159 Inhalation aerosol, 60 μg one day treatment, PA9159 Inhalation aerosol, 120 μg one day treatment and PA9159 Inhalation aerosol, 240 μg one day treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2024to 21 Sep 2024
- 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 use the nebulizer correctly, cannot tolerate nebulized inhalation administration or have failed the training for inhalation administration;
- Those with special dietary requirements and cannot follow the unified diet;
- Those with a history of chronic diseases such as cardiovascular, digestive, endocrine, hematological, immune, and nervous system diseases; those with chronic diseases of the oral, pharyngeal, and respiratory systems; those with chronic diseases of the oral, pharyngeal, and respiratory systems at the time of screening; those with a history of recurrent (defined as more than 1 episode) or disseminated herpes zoster, repeated infection, tuberculosis infection, glaucoma, or cataract;
- Those who are allergic to the study drug or any component of the study drug, or have an allergic constitution (referring to an allergic constitution to more than two drugs and foods);
- Those whose vital signs, physical examination, laboratory tests, chest X-ray examination, 12-lead electrocardiogram examination, pulmonary ventilation function examination, etc. at the screening period are judged abnormal and have clinical significance;
- Those with positive tests for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), Treponema pallidum antibody (Syphilis TP), human immunodeficiency virus (HIV Ag/Ab);
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- Those with FEV1 ≤ 80% of predicted value or FVC ≤ 80% of predicted value at the screening period;
- Those who frequently drink alcohol within 3 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of spirits with 40% alcohol content or 150 mL of wine with 12% alcohol content) or those with positive alcohol breath test at the screening period or those who cannot stop alcohol intake during the study period;
- Those with a smoking history of more than 10 years and smokers within 3 months before screening, or those who cannot stop using any tobacco products during the trial, or those with positive nicotine detection at the baseline period.
- Those who have a history of drug abuse or drug use within the past two years, or those whose urine screening for drug abuse is positive;
- Those who have taken any drugs (prescription drugs, over-the-counter drugs, Chinese herbal medicines, vaccines) or health supplements within the two weeks prior to screening or during the screening period;
- Those who have used any preparations containing glucocorticoid components or any drugs that affect the activity of CYP3A4 enzymes (such as ritonavir or ketoconazole, etc., as detailed in Appendix 5) within the 30 days prior to screening or during the screening period;
- Those who have consumed beverages or foods containing grapefruit, dragon fruit, mango, pomelo, pomegranate, papaya, or rambutan within 14 days prior to screening or during the screening period, or those who do not agree to stop consuming the above foods during the trial period;
- Those who have consumed any foods or beverages rich in caffeine, xanthine within 48 hours before the first use of the study drug (coffee, tea, cola, chocolate, seafood, animal liver, etc.), or those who do not agree to stop consuming the above foods during the trial period;
- Those who have donated blood or suffered significant blood loss within 90 days prior to screening or during the screening period (≥ 400 mL, except during the menstrual period of women) or have received blood products or undergone blood transfusion;
- Those who have participated in other clinical trials within 90 days prior to screening and have used the study product;
- Those who have undergone respiratory surgery in the past, or those who have undergone major surgery within 3 months prior to screening (judged by the investigator based on the previous medical history), suffered major trauma or planned to undergo surgery during the trial period;
- Those who have difficulty in venous blood collection, or have a known history of multiple fainting or hematemesis;
- Female subjects who have tested positive for pregnancy detection or are in lactation during the screening period or baseline period;
- Subjects who, in the opinion of the investigator, have other conditions that are not suitable for participating in the trial or who cannot participate in the trial due to their own reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of PA9159 Inhalation Aerosol in Healthy Adult Subjects in China
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 Inhalation aerosol 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 Inhalation aerosol. In the first part of the study, the treatment is given once for one day, with escalation doses of 60 μg, 120 μg, 240 μg, 300 μg. 30 health subjects will be enrolled for this part. In the second part of the study, PA9159 at the escalation dose of 120 μg is given twice a day for 7 days. 10 health subjects will be enrolled for this group, randomized proportionally at 4:1 ratio to receive either the investigational product PA9159 Inhalation aerosol or placebo , with a total of 40 subjects for this two-part study. Subjects will be evaluated for the safety, tolerability and pharmacokinetics of PA9159 Inhalation aerosol.
- Conditions
- Bronchial Asthma
- Being tested
- PA9159 Inhalation aerosol, 60 μg one day treatment, PA9159 Inhalation aerosol, 120 μg one day treatment, PA9159 Inhalation aerosol, 240 μg one day treatment, PA9159 Inhalation aerosol, 300 μg one day treatment, PA9159 Inhalation aerosol, 120 μg 7-day treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA9159 Inhalation aerosol, 60 μg one day treatmentDrug
single dose of PA9159 (60 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 2 puffs.
PA9159 Inhalation aerosol, 120 μg one day treatmentDrug
single dose of PA9159 (120 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 4 puffs.
PA9159 Inhalation aerosol, 240 μg one day treatmentDrug
single dose of PA9159 (240 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 8 puffs.
PA9159 Inhalation aerosol, 300 μg one day treatmentDrug
single dose of PA9159 (300 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 10 puffs.
PA9159 Inhalation aerosol, 120 μg 7-day treatmentDrug
Repeated doses of PA9159 (120 μg/inhaler spray) i is administered by inhalation through an inhaler via the mouth, with 4 puffs, twice a day.
Placebo, the same Inhalation aerosol solution without PA9159 active ingredientDrug
Placebo is delivered via the mouth through an inhaler with the same volume as the corresponding PA9159 dose group
| Study group | Role | What they receive |
|---|---|---|
| PA9159 60 μg single dose and placebo | Experimental | Six subjects will be randomly assigned at a 2:1 ratio to receive either single dose of 60 μg PA9159 or placebo. Before escalating to the next dose level, all available clinical and laboratory safety data will be reviewed. Receives: Drug: PA9159 Inhalation aerosol, 60 μg one day treatment; Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredient |
| PA9159 120 μg single dose and placebo | Experimental | Eight subjects will be randomly assigned in a 3:1 ratio to receive either single dose of 120 μg PA9159 or placebo. Before escalating to the next dose level, all available clinical and laboratory safety data will be reviewed. Receives: Drug: PA9159 Inhalation aerosol, 120 μg one day treatment; Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredient |
| PA9159 240 μg single dose and placebo | Experimental | Eight subjects will be randomly assigned in a 3:1 ratio to receive either single dose of 240 μg PA9159 or placebo. Before escalating to the next dose level, all available clinical and laboratory safety data will be reviewed. Receives: Drug: PA9159 Inhalation aerosol, 240 μg one day treatment; Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredient |
| PA9159 300 μg single dose and placebo | Experimental | Eight subjects will be randomly assigned in a 3:1 ratio to receive either single dose of 300 μg PA9159 or placebo. all available clinical and laboratory safety data will be reviewed. Receives: Drug: PA9159 Inhalation aerosol, 300 μg one day treatment; Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredient |
| PA9159 120 μg repeated doses and placebo | Experimental | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either 120 μg PA9159 or placebo twice a day for 7 days. all available clinical and laboratory safety data will be reviewed. Receives: Drug: PA9159 Inhalation aerosol, 120 μg 7-day treatment; Drug: Placebo, the same Inhalation aerosol 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: within 48 hours after last treatment
Number of subjects having abnormal hematology laboratory parameters
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Measured: within 48 hours after last treatment
Number of subjects with abnormal clinical chemistry parameters
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Measured: within 48 hours after last treatment
Number of subjects with abnormal values for urinalysis
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Measured: within 24 hours after last treatment
Systolic and diastolic blood pressure
Vital sign-Systolic and diastolic blood pressure
Measured: within 48 hours after last treatment
ECG parameter-QTc interval
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically calculates the QTc intervals
Measured: up to 24 hours after last treatment
Body temperature
Vital sign-Body temperature
Measured: within 48 hours after last treatment
Pulse rate
Vital sign-Pulse rate
Measured: within 48 hours after last treatment
ECG parameter-PR interval
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures PR intervals
Measured: up to 24 hours after last treatment
ECG parameter-QRS duration
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QRS duration
Measured: up to 24 hours after last treatment
Secondary outcomes (5)
Serum cortisol levels
Monitor the concentration changes of serum cortisol before and after PA9159 administration.
Measured: From pre-dose until 24 hours post-dose
Pharmacokinetics of single dose and repeat doses of inhalation aerosol PA9159
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 (Cmax）
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 inhalation aerosol PA9159
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 (Tmax)
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 inhalation aerosol PA9159
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 (AUC)
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 inhalation aerosol PA9159
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 (T1/2)
Measured: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 posted8 Apr 2025
- Study start22 Jul 2024
- Primary completion12 Sep 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies 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 1-4, the treatment is given once for one day, with escalation doses of 60 μg, 120 μg, 240 μg, 300 μg. For each dose group, 6, 8, 8 and 8 healthy subjects will be randomly assigned in a 2:1, 3:1, 3:1 and 3:1 ratio respectively to receive the test drug PA9159 inhalation aerosol or placebo. Arm 5, PA9159 at the escalation dose of 120 μg is given twice a day for 7 days. 10 health subjects will be enrolled for this dose group, randomized proportionally at 4:1 ratio to receive either the investigational product PA9159 Inhalation aerosol or placebo , with a total of 40 subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinhua Wen, phD, Principal investigator, The First Affiliated Hospital of Nanchang UniversityXiaohua Cheng, Master, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916273
- Sponsor's protocol ID
- PA9159AS-101
- Status last verified
- Dec 2025
- First submitted
- 12 Mar 2025
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of PA9159 Inhalation Aerosol in Healthy Adult Subjects in China
- ClinicalTrials.gov ID
- NCT06916273
- Acronym / sponsor ID
- PA9159AS-101
- Conditions
- Bronchial Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 8 Apr 2025 (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 Inhalation aerosol 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 Inhalation aerosol. In the first part of the study, the treatment is given once for one day, with escalation doses of 60 μg, 120 μg, 240 μg, 300 μg. 30 health subjects will be enrolled for this part. In the second part of the study, PA9159 at the escalation dose of 120 μg is given twice a day for 7 days. 10 health subjects will be enrolled for this group, randomized proportionally at 4:1 ratio to receive either the investigational product PA9159 Inhalation aerosol or placebo , with a total of 40 subjects for this two-part study. Subjects will be evaluated for the safety, tolerability and pharmacokinetics of PA9159 Inhalation aerosol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Arm 1-4, the treatment is given once for one day, with escalation doses of 60 μg, 120 μg, 240 μg, 300 μg. For each dose group, 6, 8, 8 and 8 healthy subjects will be randomly assigned in a 2:1, 3:1, 3:1 and 3:1 ratio respectively to receive the test drug PA9159 inhalation aerosol or placebo. Arm 5, PA9159 at the escalation dose of 120 μg is given twice a day for 7 days. 10 health subjects will be enrolled for this dose group, randomized proportionally at 4:1 ratio to receive either the investigational product PA9159 Inhalation aerosol or placebo , with a total of 40 subjects.
| Arm | Type | Receives |
|---|---|---|
| PA9159 60 μg single dose and placebo | Experimental | Drug: PA9159 Inhalation aerosol, 60 μg one day treatment, Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredientSix subjects will be randomly assigned at a 2:1 ratio to receive either single dose of 60 μg PA9159 or placebo. Before escalating to the next dose level, all available clinical and laboratory safety data will be reviewed. |
| PA9159 120 μg single dose and placebo | Experimental | Drug: PA9159 Inhalation aerosol, 120 μg one day treatment, Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredientEight subjects will be randomly assigned in a 3:1 ratio to receive either single dose of 120 μg PA9159 or placebo. Before escalating to the next dose level, all available clinical and laboratory safety data will be reviewed. |
| PA9159 240 μg single dose and placebo | Experimental | Drug: PA9159 Inhalation aerosol, 240 μg one day treatment, Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredientEight subjects will be randomly assigned in a 3:1 ratio to receive either single dose of 240 μg PA9159 or placebo. Before escalating to the next dose level, all available clinical and laboratory safety data will be reviewed. |
| PA9159 300 μg single dose and placebo | Experimental | Drug: PA9159 Inhalation aerosol, 300 μg one day treatment, Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredientEight subjects will be randomly assigned in a 3:1 ratio to receive either single dose of 300 μg PA9159 or placebo. all available clinical and laboratory safety data will be reviewed. |
| PA9159 120 μg repeated doses and placebo | Experimental | Drug: PA9159 Inhalation aerosol, 120 μg 7-day treatment, Drug: Placebo, the same Inhalation aerosol solution without PA9159 active ingredientTen subjects will be randomly assigned at a 4: 1 ratio to receive either 120 μg PA9159 or placebo twice a day for 7 days. all available clinical and laboratory safety data will be reviewed. |
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 use the nebulizer correctly, cannot tolerate nebulized inhalation administration or have failed the training for inhalation administration;
- Those with special dietary requirements and cannot follow the unified diet;
- Those with a history of chronic diseases such as cardiovascular, digestive, endocrine, hematological, immune, and nervous system diseases; those with chronic diseases of the oral, pharyngeal, and respiratory systems; those with chronic diseases of the oral, pharyngeal, and respiratory systems at the time of screening; those with a history of recurrent (defined as more than 1 episode) or disseminated herpes zoster, repeated infection, tuberculosis infection, glaucoma, or cataract;
- Those who are allergic to the study drug or any component of the study drug, or have an allergic constitution (referring to an allergic constitution to more than two drugs and foods);
- Those whose vital signs, physical examination, laboratory tests, chest X-ray examination, 12-lead electrocardiogram examination, pulmonary ventilation function examination, etc. at the screening period are judged abnormal and have clinical significance;
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 Inhalation aerosol, 60 μg one day treatmentsingle dose of PA9159 (60 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 2 puffs. | Drug | PA9159 60 μg single dose and placebo |
| PA9159 Inhalation aerosol, 120 μg one day treatmentsingle dose of PA9159 (120 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 4 puffs. | Drug | PA9159 120 μg single dose and placebo |
| PA9159 Inhalation aerosol, 240 μg one day treatmentsingle dose of PA9159 (240 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 8 puffs. | Drug | PA9159 240 μg single dose and placebo |
| PA9159 Inhalation aerosol, 300 μg one day treatmentsingle dose of PA9159 (300 μg/inhaler spray) is administered by inhalation through an inhaler via the mouth, with 10 puffs. | Drug | PA9159 300 μg single dose and placebo |
| PA9159 Inhalation aerosol, 120 μg 7-day treatmentRepeated doses of PA9159 (120 μg/inhaler spray) i is administered by inhalation through an inhaler via the mouth, with 4 puffs, twice a day. | Drug | PA9159 120 μg repeated doses and placebo |
| Placebo, the same Inhalation aerosol solution without PA9159 active ingredientPlacebo is delivered via the mouth through an inhaler with the same volume as the corresponding PA9159 dose group | Drug | PA9159 120 μg repeated doses and placebo, PA9159 120 μg single dose and placebo, PA9159 240 μg single dose and placebo, PA9159 300 μg single dose and placebo, PA9159 60 μg single dose and placebo |
Primary outcome
Number of subjects experiencing adverse events (AEs)
Time frame: within 48 hours after last 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.
Number of subjects having abnormal hematology laboratory parameters
Time frame: within 48 hours after last treatment
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Number of subjects with abnormal clinical chemistry parameters
Time frame: within 48 hours after last treatment
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Number of subjects with abnormal values for urinalysis
Time frame: within 24 hours after last treatment
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Systolic and diastolic blood pressure
Time frame: within 48 hours after last treatment
Vital sign-Systolic and diastolic blood pressure
ECG parameter-QTc interval
Time frame: up to 24 hours after last treatment
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically calculates the QTc intervals
Body temperature
Time frame: within 48 hours after last treatment
Vital sign-Body temperature
Pulse rate
Time frame: within 48 hours after last treatment
Vital sign-Pulse rate
ECG parameter-PR interval
Time frame: up to 24 hours after last treatment
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures PR intervals
ECG parameter-QRS duration
Time frame: up to 24 hours after last treatment
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QRS duration
5 secondary outcomes
Serum cortisol levels
Time frame: From pre-dose until 24 hours post-dose
Pharmacokinetics of single dose and repeat doses of inhalation aerosol PA9159
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 inhalation aerosol PA9159
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 inhalation aerosol PA9159
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 inhalation aerosol PA9159
Time frame: Pre-dose, and post-dose (day 1 for single dose subjects, day 1 and day 7 for repeat doses subjects)5, 10, 15, 30 minutes, 1, 1.5, 2, 3 , 4, 6, 8,12, 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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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, phD principal investigator
The First Affiliated Hospital of Nanchang University
Xiaohua Cheng, Master 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 Inhalation aerosol, 60 μg one day treatment, PA9159 Inhalation aerosol, 120 μg one day treatment and PA9159 Inhalation aerosol, 240 μg one day treatment in people with Bronchial Asthma, 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 30 Dec 2025. 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: within 48 hours after last treatment). The study lists 10 primary outcomes in all. 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 30 Dec 2025.