HealthyPhase 1NCT04200092
Staccato® Granisetron Single Dose PK
A Phase 1 study testing 1mg AZ-010, 3mg AZ-010 and AZ-010 1mg in people with Healthy, run by Nova Pneuma Inc. at 1 site in United States.
Trial summary
This study was conducted in 2 parts in separate treatment groups of healthy volunteers. Part A of the study was double-blind, randomized, and placebo-controlled; Part B is open label. The primary objectives for each part were as follows: Part A: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1mg AZ-010, 3mg AZ-010 and AZ-010 1mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 31 Jan 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
- Female subjects fulfilled the following criteria:
- Surgically sterile (including bilateral tubal ligation) for at least 3 months prior to screening
- Postmenopausal, defined as 1 of the following:
- Last menstrual sequence greater than 12 months prior to screening
- Last menstrual sequence greater than 6 months prior to screening and a serum follicle-stimulating hormone (FSH) concentration > 40 mIU/mL
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- Subjects of childbearing potential (i.e., did not meet the criteria for surgical sterility or post- menopausal status outlined above):
- Had a negative serum pregnancy test at screening and Day -1, as verified by the study doctor prior to starting study therapy
- Either committed to true abstinence from heterosexual contact or agreed to use, and was able to comply with, effective contraception without interruption with one of the following methods during the study participation up until 90 days after administration of study drug: Oral contraceptive medications, Intrauterine devices, Hormonal implants, Injectable contraceptive medications, Double barrier methods.
- Male subjects practiced true abstinence from heterosexual contact or, during sexual contact with a pregnant female or a female of childbearing potential, agreed to use a condom.
- Healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, ECGs, and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
- Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
- Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.
- Dietary habits that fell within the range of normal, as determined by the PI.
- Was willing and able to be confined at the clinical research center for the study period, and adhered to overall study visit schedule, procedures and other protocol requirements.
- Understood and voluntarily signed an ICF prior to any study related assessments/procedures being conducted.
Who cannot join
- Subject candidates were not enrolled in the study if they met any of the following criteria:
- Any significant medical condition, psychiatric illness or history of depression that could have, in the PI's opinion, compromised the subject's safety or interfered with the completion of this study.
- Any condition, including the presence of laboratory abnormalities or abnormal pulmonary function test, which according to the PI, placed the subject at unacceptable risk if he/she were to participate in the study.
- Any condition that according to the PI confounded the ability to interpret data from the study such as a virus, seasonal allergy, concurrent skin rash, etc. at screening or prior to drug treatment phase that may have been difficult to discern from further health status changes from an investigational product.
- History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary (e.g., asthma, chronic obstructive pulmonary disease), metabolic, renal, hepatic, or gastrointestinal (GI) conditions including gastric bypass or other weight loss surgical procedure; or history of such conditions that, in the opinion of the PI, may have placed the subject at an unacceptable risk as a participant in this trial, may have interfered with the interpretation of safety and/or tolerability data obtained in the trial, or may have interfered with the absorption, distribution, metabolism, or excretion of the study drugs.
- Used drugs known to prolong the corrected QT interval (QTc).
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- PR interval > 220 msec or QRS duration > 120 msec or Fridericia's corrected QT interval (QTcF) > 450 msec for men and > 470 msec for women obtained at the screening visit or prior to the first dose of study drug.
- Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), serum creatinine, or total bilirubin > 1.5 upper limit of normal (ULN) at screening or prior to the first dose of study drug.
- Positive blood screen for HIV antibody, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening.
- History of drug or alcohol abuse within 6 months of screening.
- History of any tobacco product use within 3 months prior to the study.
- Participation in a clinical trial and receipt of an investigational medication or a new chemical entity within 90 days, 5 half-lives, if known, or twice the duration of the biological effect of any medication (whichever is longer) prior to the first dose of current study drug.
- Use of non-prescription medications, including herbal and dietary supplements within 5 days or 5 half-lives (whichever was longer) prior to the first dose of study drug.
- Use of any 5-HT3 receptor antagonists or any other serotonergic drugs, including selective serotonergic reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) within 5 days or 5 half-lives (whichever is longer) prior to screening.
- Consumption of any caffeine and/or xanthine products (i.e., coffee, tea, chocolate and caffeine containing sodas, colas, etc.) within 24 hours prior to entry to the clinical unit on Day -1.
- Donation of blood, plasma, or other blood products or blood collection in excess of 470 mL within 8 weeks prior to dosing.
- Known history of sensitivity to any of the study drugs or components thereof, or to other 5-HT3 receptor antagonists, or a history of medication allergy or other allergy that, in the opinion of the PI, contraindicated study participation.
- Major surgery within 4 weeks of screening that could have interfered with, or for which the treatment might have interfered with, the conduct of the study, or that would have posed an unacceptable risk to the subject in the opinion of the PI.
- Uncontrolled current illness (i.e., active infection).
- Had current or a history of cancer, with the exception of basal cell carcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Part Study Investigating the Safety and pk of Single Ascending Doses of Staccato Granisetron (AZ-010) and Crossover Comparison of the Pharmacokinetics and Safety of AZ-010 and Intravenous Granisetron in Healthy Volunteers
This study was conducted in 2 parts in separate treatment groups of healthy volunteers. Part A of the study was double-blind, randomized, and placebo-controlled; Part B is open label.
The primary objectives for each part were as follows:
Read more
Part A:
- To examine the tolerability and safety of single ascending doses up to 3 mg of AZ-010 (Staccato Granisetron) in healthy volunteers
- To characterize the pharmacokinetics (PK) of single ascending doses up to 3 mg of AZ-010 in healthy volunteers
Part B:
- To compare the PK and safety of a single dose of 1 mg of AZ-010 with that of 1 mg granisetron hydrochloride intravenous (IV) injection in healthy volunteers.
The 2 parts to the study were performed sequentially.
Read the detailed description
Part A assessed single ascending orally inhaled doses of AZ-010 in a double-blind, placebo controlled design. The planned AZ-010 doses to be studied were 0.5 mg, 1 mg, and 3 mg delivered from 1 device each.
There were 3 cohorts of at least 8 subjects each, with at least 2 males and 2 females in each cohort. Each subject received a single dose of AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo per cohort.
Upon completion of each cohort, a review of the in-clinic safety and tolerability data was performed by the Principal Investigator (PI), Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose up to 3 mg.
Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B. PK data were analyzed and assessed through blood samples obtained for Parts A and B.
Part B Approximately 12 healthy volunteers were enrolled in this 2-period, 2-treatment open-label crossover design study assessing the PK profiles of AZ-010 (1 mg) and IV granisetron (1 mg).
Eligible consenting subjects were randomized to 1 of 2 treatment sequences, with a total of 12 subjects (6 subjects in each sequence, with at least 2 males and 2 females in each sequence).
Treatment periods were separated by at least a 3-day washout between doses.
- Conditions
- Healthy
- Being tested
- 0.5mg AZ-010; placebo, 1mg AZ-010, 3mg AZ-010, AZ-010 1mg, IV Granisetron 1mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5mg AZ-010; placeboCombination product
Also called Staccato Granisetron 0.5 mg
Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
1mg AZ-010Combination product
Also called Staccato Granisetron 1mg
Subject will receive a single inhaled dose (1.0 mg) of AZ-010 or matching Staccato Placebo
3mg AZ-010Combination product
Also called Staccato Granisetron 3mg
Subject will receive a single inhaled dose (3.0 mg) of AZ-010 or matching Staccato Placebo
AZ-010 1mgCombination product
Also called Staccato Granisetron 1mg
2-period, 2-treatment open-label crossover design
IV Granisetron 1mgDrug
Also called Granisetron HCl, supplied as a 1 mg/mL solution (Lot No. 061488A)
2-period, 2-treatment open-label crossover design
PlaceboOther
Participants in Part A, Cohorts 1, 2, and 3, double-blind, randomized, and placebo-controlled study who received placebo.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1 | Experimental | A single oral dose of 0.5 mg AZ-010 (Staccato Granisetron) administered to 8 subjects, with at least 2 males and 2 females. Each subject received a single dose of 0.5 mg AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo.
Upon completion of the cohort, a review of the in-clinic safety and tolerability data was performed by the PI, Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose. Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B.
Each subject participated for up to 4 weeks, depending upon the timing of screening.
Subjects were confined to the clinic for 4 days (3 nights). A follow-up phone call was conducted, approximately 7 days after the subject left the CRU. Receives: Combination Product: 0.5mg AZ-010; placebo |
| Part A: Cohort 2 | Experimental | A single oral dose of 1 mg AZ-010 (Staccato Granisetron) administered to 8 subjects, with at least 2 males and 2 females. Each subject received a single dose of 1 mg AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo.
Upon completion of the cohort, a review of the in-clinic safety and tolerability data was performed by the PI, Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose. The single daily dose did not exceed 3 mg. Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B.
Each subject participated for up to 4 weeks, depending upon the timing of screening.
Subjects were confined to the clinic for 4 days (3 nights). A follow-up phone call was conducted, approximately 7 days after the subject left the CRU. Receives: Combination Product: 1mg AZ-010 |
| Part A: Cohort 3 | Experimental | A single oral dose of 3 mg AZ-010 (Staccato Granisetron) administered to 8 subjects, with at least 2 males and 2 females. Each subject received a single dose of 3 mg AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo.
Upon completion of the cohort, a review of the in-clinic safety and tolerability data was performed by the PI, Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose. The single daily dose did not exceed 3 mg. Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B.
Each subject participated for up to 4 weeks, depending upon the timing of screening.
Subjects were confined to the clinic for 4 days (3 nights). A follow-up phone call was conducted, approximately 7 days after the subject left the CRU. Receives: Combination Product: 3mg AZ-010 |
| Part B: Sequence 1 | Active comparator | A single inhalation dose of 1 mg AZ-010, followed by IV injection granisetron 1mg, 2-period, a 2-treatment open-label crossover design.
Participants were randomized in a 1:1 ratio to 1 of 2 sequences. Period 1 began with the inhalation dose of AZ-010 1mg and after a three-day washout participants were crossed over to the other sequence for Period 2 with the treatment of IV injection granisetron 1 mg dose.
There was a total of 12 subjects (6 subjects in each sequence, with at least 2 males and 2 females in each sequence). Sequence 1 participants crossed over to Sequence 2 after washout. Receives: Combination Product: AZ-010 1mg; Drug: IV Granisetron 1mg |
| Part B: Sequence 2 | Active comparator | Treatment of 1 mg (IV) granisetron followed by a single inhalation dose of AZ-010 1mg, a 2-period, 2-treatment open-label crossover design.
Part B Sequence 2 participants began with Period 1 treatment of IV injection granisetron 1 mg dose and after a three-day washout participants were crossed over to the other sequence for Period 2 with the inhalation dose of AZ-010 1mg.
There was a total of12 subjects (6 subjects in each sequence, with at least 2 males and 2 females in each sequence). Sequence 2 participants crossed over to Sequence 1 after washout. Receives: Combination Product: AZ-010 1mg; Drug: IV Granisetron 1mg |
| Pooled Placebo, Cohort 1, 2, 3 Part A | Placebo comparator | Participants in Part A, Cohorts 1, 2, and 3, double-blind, randomized, and placebo-controlled study who received placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Measured: 3 days
Measurement of Granisetron Exposure in Plasma
AUC (area under the curve)
Measured: 3 days
Measurement of Granisetron Maximum Exposure in Plasma
Cmax
Measured: 3 days
Measurement of Granisetron Time to Maximum Exposure in Plasma
Tmax
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start4 Nov 2019
- Primary completion10 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Pneuma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Phillip Mathew, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200092
- Sponsor's protocol ID
- AMDC-010-101
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Study Investigating the Safety and pk of Single Ascending Doses of Staccato Granisetron (AZ-010) and Crossover Comparison of the Pharmacokinetics and Safety of AZ-010 and Intravenous Granisetron in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04200092
- Acronym / sponsor ID
- AMDC-010-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nova Pneuma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 16 Dec 2019 (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.
This study was conducted in 2 parts in separate treatment groups of healthy volunteers. Part A of the study was double-blind, randomized, and placebo-controlled; Part B is open label.
The primary objectives for each part were as follows:
Part A:
- To examine the tolerability and safety of single ascending doses up to 3 mg of AZ-010 (Staccato Granisetron) in healthy volunteers
- To characterize the pharmacokinetics (PK) of single ascending doses up to 3 mg of AZ-010 in healthy volunteers
Part B:
- To compare the PK and safety of a single dose of 1 mg of AZ-010 with that of 1 mg granisetron hydrochloride intravenous (IV) injection in healthy volunteers.
The 2 parts to the study were performed sequentially.
Detailed description
Part A assessed single ascending orally inhaled doses of AZ-010 in a double-blind, placebo controlled design. The planned AZ-010 doses to be studied were 0.5 mg, 1 mg, and 3 mg delivered from 1 device each.
There were 3 cohorts of at least 8 subjects each, with at least 2 males and 2 females in each cohort. Each subject received a single dose of AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo per cohort.
Upon completion of each cohort, a review of the in-clinic safety and tolerability data was performed by the Principal Investigator (PI), Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose up to 3 mg.
Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B. PK data were analyzed and assessed through blood samples obtained for Parts A and B.
Part B Approximately 12 healthy volunteers were enrolled in this 2-period, 2-treatment open-label crossover design study assessing the PK profiles of AZ-010 (1 mg) and IV granisetron (1 mg).
Eligible consenting subjects were randomized to 1 of 2 treatment sequences, with a total of 12 subjects (6 subjects in each sequence, with at least 2 males and 2 females in each sequence).
Treatment periods were separated by at least a 3-day washout between doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1 | Experimental | Combination Product: 0.5mg AZ-010; placeboA single oral dose of 0.5 mg AZ-010 (Staccato Granisetron) administered to 8 subjects, with at least 2 males and 2 females. Each subject received a single dose of 0.5 mg AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo. Upon completion of the cohort, a review of the in-clinic safety and tolerability data was performed by the PI, Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose. Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B. Each subject participated for up to 4 weeks, depending upon the timing of screening. Subjects were confined to the clinic for 4 days (3 nights). A follow-up phone call was conducted, approximately 7 days after the subject left the CRU. |
| Part A: Cohort 2 | Experimental | Combination Product: 1mg AZ-010A single oral dose of 1 mg AZ-010 (Staccato Granisetron) administered to 8 subjects, with at least 2 males and 2 females. Each subject received a single dose of 1 mg AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo. Upon completion of the cohort, a review of the in-clinic safety and tolerability data was performed by the PI, Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose. The single daily dose did not exceed 3 mg. Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B. Each subject participated for up to 4 weeks, depending upon the timing of screening. Subjects were confined to the clinic for 4 days (3 nights). A follow-up phone call was conducted, approximately 7 days after the subject left the CRU. |
| Part A: Cohort 3 | Experimental | Combination Product: 3mg AZ-010A single oral dose of 3 mg AZ-010 (Staccato Granisetron) administered to 8 subjects, with at least 2 males and 2 females. Each subject received a single dose of 3 mg AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo. Upon completion of the cohort, a review of the in-clinic safety and tolerability data was performed by the PI, Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose. The single daily dose did not exceed 3 mg. Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B. Each subject participated for up to 4 weeks, depending upon the timing of screening. Subjects were confined to the clinic for 4 days (3 nights). A follow-up phone call was conducted, approximately 7 days after the subject left the CRU. |
| Part B: Sequence 1 | Active comparator | Combination Product: AZ-010 1mg, Drug: IV Granisetron 1mgA single inhalation dose of 1 mg AZ-010, followed by IV injection granisetron 1mg, 2-period, a 2-treatment open-label crossover design. Participants were randomized in a 1:1 ratio to 1 of 2 sequences. Period 1 began with the inhalation dose of AZ-010 1mg and after a three-day washout participants were crossed over to the other sequence for Period 2 with the treatment of IV injection granisetron 1 mg dose. There was a total of 12 subjects (6 subjects in each sequence, with at least 2 males and 2 females in each sequence). Sequence 1 participants crossed over to Sequence 2 after washout. |
| Part B: Sequence 2 | Active comparator | Combination Product: AZ-010 1mg, Drug: IV Granisetron 1mgTreatment of 1 mg (IV) granisetron followed by a single inhalation dose of AZ-010 1mg, a 2-period, 2-treatment open-label crossover design. Part B Sequence 2 participants began with Period 1 treatment of IV injection granisetron 1 mg dose and after a three-day washout participants were crossed over to the other sequence for Period 2 with the inhalation dose of AZ-010 1mg. There was a total of12 subjects (6 subjects in each sequence, with at least 2 males and 2 females in each sequence). Sequence 2 participants crossed over to Sequence 1 after washout. |
| Pooled Placebo, Cohort 1, 2, 3 Part A | Placebo comparator | Other: PlaceboParticipants in Part A, Cohorts 1, 2, and 3, double-blind, randomized, and placebo-controlled study who received placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy adult males and females between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
- Female subjects fulfilled the following criteria:
- Male subjects practiced true abstinence from heterosexual contact or, during sexual contact with a pregnant female or a female of childbearing potential, agreed to use a condom.
- Healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, ECGs, and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
- Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
Key exclusion criteria (20 listed)
- Subject candidates were not enrolled in the study if they met any of the following criteria:
- Any significant medical condition, psychiatric illness or history of depression that could have, in the PI's opinion, compromised the subject's safety or interfered with the completion of this study.
- Any condition, including the presence of laboratory abnormalities or abnormal pulmonary function test, which according to the PI, placed the subject at unacceptable risk if he/she were to participate in the study.
- Any condition that according to the PI confounded the ability to interpret data from the study such as a virus, seasonal allergy, concurrent skin rash, etc. at screening or prior to drug treatment phase that may have been difficult to discern from further health status changes from an investigational product.
- History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary (e.g., asthma, chronic obstructive pulmonary disease), metabolic, renal, hepatic, or gastrointestinal (GI) conditions including gastric bypass or other weight loss surgical procedure; or history of such conditions that, in the opinion of the PI, may have placed the subject at an unacceptable risk as a participant in this trial, may have interfered with the interpretation of safety and/or tolerability data obtained in the trial, or may have interfered with the absorption, distribution, metabolism, or excretion of the study drugs.
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 |
|---|---|---|
| 0.5mg AZ-010; placeboAlso: Staccato Granisetron 0.5 mgSubject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo | Combination product | Part A: Cohort 1 |
| 1mg AZ-010Also: Staccato Granisetron 1mgSubject will receive a single inhaled dose (1.0 mg) of AZ-010 or matching Staccato Placebo | Combination product | Part A: Cohort 2 |
| 3mg AZ-010Also: Staccato Granisetron 3mgSubject will receive a single inhaled dose (3.0 mg) of AZ-010 or matching Staccato Placebo | Combination product | Part A: Cohort 3 |
| AZ-010 1mgAlso: Staccato Granisetron 1mg2-period, 2-treatment open-label crossover design | Combination product | Part B: Sequence 1, Part B: Sequence 2 |
| IV Granisetron 1mgAlso: Granisetron HCl, supplied as a 1 mg/mL solution (Lot No. 061488A)2-period, 2-treatment open-label crossover design | Drug | Part B: Sequence 1, Part B: Sequence 2 |
| PlaceboParticipants in Part A, Cohorts 1, 2, and 3, double-blind, randomized, and placebo-controlled study who received placebo. | Other | Pooled Placebo, Cohort 1, 2, 3 Part A |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 3 days
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Measurement of Granisetron Exposure in Plasma
Time frame: 3 days
AUC (area under the curve)
Measurement of Granisetron Maximum Exposure in Plasma
Time frame: 3 days
Cmax
Measurement of Granisetron Time to Maximum Exposure in Plasma
Time frame: 3 days
Tmax
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 13 Apr 2026.
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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.
Phillip Mathew, MD principal investigator
Celerion
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 1mg AZ-010, 3mg AZ-010 and AZ-010 1mg in people with Healthy, run by Nova Pneuma Inc. at 1 site in United States.
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 16 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 13 Apr 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 United States. 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. Some participants in this study may receive a placebo. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: 3 days). The study lists 4 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 13 Apr 2026.