Allergic RhinitisPhase 1NCT05170763
Safety, Tolerability, and Pharmacokinetics of PA9159 Nasal Spray in Healthy Adult Subjects
A Phase 1 study testing PA9159 nasal spray solution, 10 μg one day treatment, PA9159 nasal spray solution, 20 μg one day treatment and PA9159 nasal spray solution, 40 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, 10 μg one day treatment, PA9159 nasal spray solution, 20 μg one day treatment and PA9159 nasal spray solution, 40 μg one day treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2021to 5 Jan 2022
- 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 28 kg/m2 (including cut-off values);
- Voluntary participation and signing of informed consent.
Who cannot join
- Those with a history or current history of serious diseases such as respiratory, cardiovascular, digestive, endocrine, hematological, immune, psychiatric, neurological, and otologic diseases, with special attention to a history of recurrent (defined as > 1) or disseminated herpes zoster, history of recurrent infections, tuberculosis infection, glaucoma and cataract; Suffering from acute, chronic or local infectious diseases (e.g., eye, nose infection, etc.);
- Those who are allergic to the study drug or any component of the study drug (refer to the susceptibility of the body to allergic reactions, or to a variety of food, drugs, or environmental substances);
- Any past or current medical history that may affect the safety of the study in the body, especially any nasal disorder affecting drug absorption: a) History of long-term nasal congestion, rhinorrhea, nasal pruritus, headache, epistaxis, etc.; b) asthma, aspirin stress response, chronic respiratory disease, etc.; c) History of nasal surgery, trauma, allergic rhinitis, chronic rhinitis, sinusitis, severe deviation of nasal septum, etc., and the researchers believe that it is still clinically significant;
- Abnormal and clinically significant vital signs, physical examination, nasal examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation function, serum cortisol), ECG, etc., during screening;
- Positive test results and have clinical significance for human immunodeficiency virus HIV-P24 antigen/antibody, hepatitis C virus (HCV) antibody, treponema pallidum (TP), or hepatitis B five items (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B e antigen, hepatitis B e antibody, and hepatitis B core antibody);
- Regular drinkers within 6 months prior to screening,That is, drink more than 14 units of alcohol per week (1 unit = 360 mL of beer containing 5% alcohol or 45 mL of spirits with 40% alcohol or 150 mL of wine with 12% alcohol content) or who have a positive alcohol breath test at screening or who cannot stop alcohol intake during the study;
Show all 19Show fewer
- Smoking more than 5 cigarettes per day on average within 3 months prior to screening, or unable to discontinue the use of any tobacco products during the trial;
- History of drug abuse, history of drug abuse, or positive urine screening for drug abuse (including morphine, methamphetamine, ketamine, dimethyldioxymethamphetamine, tetrahydrocannabinol acid);
- Those who have taken any drugs (prescription drugs, over-the-counter drugs, Chinese herbal medicines, vaccines) or health products within 2 weeks prior to screening and during screening;
- Those who have used glucocorticoid-containing preparations or any drugs that affect CYP3A4 enzyme activity (e.g., ritonavir or ketoconazole, etc.) within 30 days prior to screening and during screening;
- Consumption of beverages or foods containing grapefruit, dragon fruit, mango, grapefruit, pomegranate, papaya, carambola within 14 days prior to screening and during screening, or who do not agree to stop eating the above-mentioned diet during the study;
- Consumption of any caffeine- and xanthine-rich food or beverages (coffee, tea, cola, chocolate, seafood, animal liver, etc.) within 48 hours prior to the first dose of study drug, or who do not agree to stop eating these diets during the study;
- It cannot be guaranteed that effective contraceptive measures or fertility planners or sperm or egg donors are taken during the trial and for at least 1 year after the last dose;
- Donation or massive blood loss (≥ 300 mL, except during female physiology) or use of blood products or transfusions within 90 days prior to screening and during screening;
- Participating in other clinical investigators or subjects participating in other clinical trials within 90 days prior to screening for less than 7 days;
- Major surgery (as judged by the investigator based on past medical history data), major trauma, or planned surgery during the study within 6 months prior to screening;
- Difficulty in venous blood collection, or a known history of multiple needle sickness and blood sickness;
- Women with a positive pregnancy test or breastfeeding;
- Other conditions that, in the opinion of the investigator, are not suitable for participation in the study or the subject is unable to participate in the study due to his/her own reasons.
Trial locations and contacts
1 site in 1 country.
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 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
- Being tested
- 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
- 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, 10 μg one day treatmentDrug
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.
PA9159 nasal spray solution, 20 μg one day treatmentDrug
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.
PA9159 nasal spray solution, 40 μg one day treatmentDrug
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.
PA9159 nasal spray solution, 80 μg one day treatmentDrug
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.
PA9159 nasal spray solution, 20 μg 7-day treatmentDrug
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.
PA9159 nasal spray solution, 40 μg 7-day treatmentDrug
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, 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 10 μg single dose and placebo | Experimental | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 10 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 10 μg one day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 20 μg single dose and placebo | Experimental | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 20 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 20 μg one day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 40 μg single dose and placebo | Experimental | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 40 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 40 μg one day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 80 μg single dose and placebo | Experimental | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 80 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data. Receives: Drug: PA9159 nasal spray solution, 80 μg one day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 20 μg repeated doses and placebo | Experimental | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either 20 μg PA9159 or placebo once a day for 7 days. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. Receives: Drug: PA9159 nasal spray solution, 20 μg 7-day treatment; Drug: Placebo, the same intranasal spray solution without PA9159 active ingredient |
| PA9159 40 μg repeated doses and placebo | Experimental | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either 40 μg PA9159 or placebo once a day for 7 days. There will be a one week follow-up period to review all available clinical and laboratory safety data. Receives: Drug: PA9159 nasal spray solution, 40 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
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 24 hours after last nasal spray 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 24 hours after last nasal spray 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 nasal spray treatment
Body temperature
Vital sign-Body temperature
Measured: up to 24 hours after last nasal spray treatment
Systolic and diastolic blood pressure
Vital sign-Systolic and diastolic blood pressure
Measured: up to 24 hours after last nasal spray treatment
Pulse rate
Vital sign-Pulse rate
Measured: up to 24 hours after last nasal spray 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 nasal spray 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 nasal spray 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 nasal spray treatment
Numbers of subjects experiencing local nasal/throat irritation symptoms
Self reported local irritation symptoms including pruritus, dryness, sneezing, nasal congestion, rhinorrhea, dry cough and odynophagia
Measured: up to 24 hours after nasal spray treatment
Numbers of subjects showing signs of local reactions
Visual nasal examination will be conducted by a trained physician for presence of nasal cavity erythema, edema, epistaxis, perforation of the nasal septum, or any abnormal finding deemed clinically significant.
Measured: up to 24 hours after nasal spray 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 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) 10, 20, 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 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) 10, 20, 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 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) 10, 20, 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 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) 10, 20, 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 posted28 Dec 2021
- Study start10 Nov 2021
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
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 1-4, 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170763
- Sponsor's protocol ID
- PA9159-101
- Status last verified
- Jan 2022
- First submitted
- 28 Sep 2021
- Last updated
- 19 Jan 2022
- 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 19 Jan 2022. 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
- NCT05170763
- Acronym / sponsor ID
- PA9159-101
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 28 Dec 2021 (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 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.
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 1-4, 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.
| Arm | Type | Receives |
|---|---|---|
| PA9159 10 μg single dose and placebo | Experimental | Drug: PA9159 nasal spray solution, 10 μg one day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTen subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 10 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| PA9159 20 μg single dose and placebo | Experimental | Drug: PA9159 nasal spray solution, 20 μg one day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTen subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 20 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| PA9159 40 μg single dose and placebo | Experimental | Drug: PA9159 nasal spray solution, 40 μg one day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTen subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 40 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| 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 ingredientTen subjects will be randomly assigned at a 4: 1 ratio to receive either single dose of 80 μg PA9159 or placebo. There will be a one week follow-up period to review all available clinical and laboratory safety data. |
| PA9159 20 μg repeated doses and placebo | Experimental | Drug: PA9159 nasal spray solution, 20 μg 7-day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTen subjects will be randomly assigned at a 4: 1 ratio to receive either 20 μg PA9159 or placebo once a day for 7 days. There will be a one week follow-up period to review all available clinical and laboratory safety data before escalating to next dosing level. |
| PA9159 40 μg repeated doses and placebo | Experimental | Drug: PA9159 nasal spray solution, 40 μg 7-day treatment, Drug: Placebo, the same intranasal spray solution without PA9159 active ingredientTen subjects will be randomly assigned at a 4: 1 ratio to receive either 40 μg PA9159 or placebo once a day for 7 days. There will be a one week 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 28 kg/m2 (including cut-off values);
- Voluntary participation and signing of informed consent.
Key exclusion criteria (19 listed)
- Those with a history or current history of serious diseases such as respiratory, cardiovascular, digestive, endocrine, hematological, immune, psychiatric, neurological, and otologic diseases, with special attention to a history of recurrent (defined as > 1) or disseminated herpes zoster, history of recurrent infections, tuberculosis infection, glaucoma and cataract; Suffering from acute, chronic or local infectious diseases (e.g., eye, nose infection, etc.);
- Those who are allergic to the study drug or any component of the study drug (refer to the susceptibility of the body to allergic reactions, or to a variety of food, drugs, or environmental substances);
- Any past or current medical history that may affect the safety of the study in the body, especially any nasal disorder affecting drug absorption: a) History of long-term nasal congestion, rhinorrhea, nasal pruritus, headache, epistaxis, etc.; b) asthma, aspirin stress response, chronic respiratory disease, etc.; c) History of nasal surgery, trauma, allergic rhinitis, chronic rhinitis, sinusitis, severe deviation of nasal septum, etc., and the researchers believe that it is still clinically significant;
- Abnormal and clinically significant vital signs, physical examination, nasal examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation function, serum cortisol), ECG, etc., during screening;
- Positive test results and have clinical significance for human immunodeficiency virus HIV-P24 antigen/antibody, hepatitis C virus (HCV) antibody, treponema pallidum (TP), or hepatitis B five items (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B e antigen, hepatitis B e antibody, and hepatitis B core antibody);
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, 10 μg one day treatmentSingle 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 10 μg single dose and placebo |
| PA9159 nasal spray solution, 20 μg one day treatmentSingle 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 20 μg single dose and placebo |
| PA9159 nasal spray solution, 40 μg one day treatmentSingle 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 40 μg single dose and placebo |
| PA9159 nasal spray solution, 80 μg one day treatmentSingle 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 80 μg single dose and placebo |
| PA9159 nasal spray solution, 20 μg 7-day treatmentRepeated 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 20 μg repeated doses and placebo |
| PA9159 nasal spray solution, 40 μg 7-day treatmentRepeated 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 | PA9159 40 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 10 μg single dose and placebo, PA9159 20 μg repeated doses and placebo, PA9159 20 μg single dose and placebo, PA9159 40 μg repeated doses and placebo, PA9159 40 μg single dose 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.
Number of subjects having abnormal hematology laboratory parameters
Time frame: within 24 hours after last nasal spray 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 24 hours after last nasal spray 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 nasal spray treatment
Absolute and relative number of subjects with values below, within or above the normal range will be assessed.
Body temperature
Time frame: up to 24 hours after last nasal spray treatment
Vital sign-Body temperature
Systolic and diastolic blood pressure
Time frame: up to 24 hours after last nasal spray treatment
Vital sign-Systolic and diastolic blood pressure
Pulse rate
Time frame: up to 24 hours after last nasal spray treatment
Vital sign-Pulse rate
ECG parameter-QTc interval
Time frame: up to 24 hours after last nasal spray treatment
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically calculates the QTc intervals
ECG parameter-PR interval
Time frame: up to 24 hours after last nasal spray 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 nasal spray treatment
A 12 lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QRS duration
Numbers of subjects experiencing local nasal/throat irritation symptoms
Time frame: up to 24 hours after nasal spray treatment
Self reported local irritation symptoms including pruritus, dryness, sneezing, nasal congestion, rhinorrhea, dry cough and odynophagia
Numbers of subjects showing signs of local reactions
Time frame: up to 24 hours after nasal spray treatment
Visual nasal examination will be conducted by a trained physician for presence of nasal cavity erythema, edema, epistaxis, perforation of the nasal septum, or any abnormal finding deemed clinically significant.
5 secondary outcomes
Serum cortisol levels
Time frame: From pre-dose until 24 hours post-dose
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) 10, 20, 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 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) 10, 20, 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 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) 10, 20, 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 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) 10, 20, 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 19 Jan 2022.
- 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.
Luo Zhang principal investigator
Beijing Tongren Hospital
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, 10 μg one day treatment, PA9159 nasal spray solution, 20 μg one day treatment and PA9159 nasal spray solution, 40 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 19 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 19 Jan 2022. 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). The study lists 12 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 19 Jan 2022.