CancerPhase 1NCT06953453
A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors
A Phase 1 study testing Inhaled Fentanyl Aerosol and Fentanyl Citrate Injection in people with Cancer, run by Lee's Pharmaceutical Limited at 2 sites in China.
Trial summary
This study is a single-dose, open-label, 2-cycle crossover design, comparing the pharmacokinetic parameters and safety of Inhaled Fentanyl Aerosol and intravenous fentanyl injection. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cancer
- What is being tested?
- Inhaled Fentanyl Aerosol and Fentanyl Citrate Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 23 Sep 2025to 20 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteer to participate, understand and sign the informed consent form before conducting the evaluation project;
- Male or female subjects, aged between 18 and 55, including 18 and 55 years old;
- Patients with malignant tumors diagnosed by histology or cytology;
- Body Mass Index (BMI) is >21 kg/m2, but <30 kg/m2;
- Have sufficient hematopoietic function and organ function within the last 14 days at random.
- The absolute neutrophil count is ≥1.5×109/L (has not received colony stimulating factor treatment within 14 days before the examination);
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- Platelet count ≥80×109/L (without transfusion of platelets or other platelet-increasing drugs within 14 days before the examination);
- Hemoglobin ≥90g/L (without transfusion or treatment with other hemoglobin-increasing drugs within 7 days before the examination);
- Creatinine clearance rate (Ccr)≥30 ml/min, Cr≤2 times the upper limit of normal value;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be ≤2.5×ULN, and for subjects with liver metastasis, it should be ≤5×ULN; total bilirubin should be ≤2 times the upper limit of normal value;
- Coagulation function INR≤1.5 ULN;
- In a non-oxygen-absorbing state, the oxygen saturation (from a pulse oximeter) is SaO2>95%; pulmonary function shows FEV1/FVC>70% and FEV1 as a percentage of the predicted value is>80%;
- All patients must agree to take effective contraceptive measures during the study and within one month after stopping treatment. Female patients of childbearing age must have a negative blood pregnancy test before administration;
- The ECOG performance status score is 0~1 points;
Who cannot join
- known or suspected allergy to opioids;
- used opioids within 14 days before the first administration, including but not limited to: codeine, dihydrocodeine, hydromorphone, oxycodone, methadone, morphine, fentanyl and pethidine (pethidine);
- plan to receive radiotherapy and / or systemic chemotherapy within 14 days before the first administration or during the study period (except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable);
- within 14 days before the first administration, the patient had received any monoamine oxidase (MAO) inhibitors (such as phenelzine, isocarbazine, chlorogiline, toloxadone, moclobemide, selegiline, rasagiline, etc.); Or have used CYP3A4 inhibitors (such as indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, nefazodone, ketoconazole, telithromycin, arepitan, erythromycin, fluconazole, grapefruit, verapamil, diltiazem, cimetidine, etc.) or CYP3A4 inducers (such as phenobarbital, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifabutin, rifampicin);
- have participated in other clinical studies or received surgical treatment within 30 days before the screening period, or have surgery plans during the study period;
- subjects who smoked more than 10 cigarettes / day within 3 months before the screening period;
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- subjects with a history of drug or alcohol dependence or abuse within 2 years before the screening period;
- subjects often eat food rich in xanthine (such as drinking more than 5 cups of coffee or food containing the same amount of xanthine every day);
- subjects with hypotension (systolic blood pressure <90 mmHg, or diastolic blood pressure <60 mmHg) or uncontrollable hypertension (refers to systolic blood pressure ≥ 160 mmHg, and / or diastolic blood pressure ≥ 100 mmHg after standard treatment);
- After antiviral treatment, HBV DNA>500 IU/mL or>2500 copies/mL; HCV-RNA positive; Positive for human immunodeficiency virus antibodies; Or positive for syphilis antibodies;
- subjects with positive alcohol test or urine test at any visit of the study;
- subjects with an expected survival time of <1 year;
- subjects with clinically significant ECG abnormalities during screening;
- subjects with a history of lung diseases (asthma, bronchitis, bronchospasm, emphysema, interstitial lung disease, pulmonary fibrosis, etc., excluding lung malignancies);
- subjects with history of unstable angina pectoris, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), stroke, transient ischemic attack (TIA) or major neurological diseases;
- presence of meningeal metastasis or CNS metastasis requiring clinical intervention or malignancy related epilepsy;
- women of childbearing age or lactating women with positive blood and urine pregnancy tests;
- the investigator believes that any other situation that may affect the subject's provision of informed consent or compliance with the trial protocol, or the subject's participation in the trial may affect the trial results or their own safety.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Haiyan Hu, doctor, +86 18930174575, xurill04@163.com
- Recruiting
Henan Tumor Hospital
Zhengzhou, Henan, 450008
Luo Suxia, doctor, +86 0371-65587320, luosxrm@163.com
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Malignant Tumors
This study is a single-dose, open-label, 2-cycle crossover design, comparing the pharmacokinetic parameters and safety of Inhaled Fentanyl Aerosol and intravenous fentanyl injection.
Read the detailed description
Consenting patients who met inclusion and exclusion criteria were allowed to enter the study. The subjects will be randomly assigned (1:1) to receive an intravenous bolus (5 seconds) of 25μg fentanyl injection in the first cycle, and after a 2-week washout period, to receive a single dose of 25μg inhaled fentanyl aerosol through the Staccato delivery system in the second cycle; or to receive the same treatment in the opposite order.
- Conditions
- Cancer
- Being tested
- Inhaled Fentanyl Aerosol, Fentanyl Citrate Injection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Fentanyl AerosolDrug
The subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg Fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg Fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order.
Fentanyl Citrate InjectionDrug
The subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Inhaled fentanyl aerosol | Experimental | Subjects will be randomly assigned (1:1) to either drug sequence Receives: Drug: Inhaled Fentanyl Aerosol |
| Active Comparator:Fentanyl Citrate Injection | Active comparator | Subjects will be randomly assigned (1:1) to either drug sequence Receives: Drug: Fentanyl Citrate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Concentration
Measured: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Tmax
Time to Maximum Concentration
Measured: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Ke
Terminal Elimination Rate
Measured: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
T1/2
Terminal elimination half-life
Measured: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
CL/F
Apparent Clearance (CL/F)
Measured: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
AUC_last
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration
Measured: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
AUC_inf
Area Under the Concentration-Time Curve from Time Zero to Infinity
Measured: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Secondary outcomes (1)
Pupil diameter
Measure the pupil diameter using a pupillometer.
Measured: Pupil measurements were taken before administration, and at 1, 2, 3, 5 , 10 , 30minutes , and 1, 2, 4, 8, 12 and 18hours after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start23 Sep 2025
- Primary completion20 Jul 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haiyan Hu, doctor, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953453
- Sponsor's protocol ID
- ZK07
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2025
- Last updated
- 25 Sep 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Malignant Tumors
- ClinicalTrials.gov ID
- NCT06953453
- Acronym / sponsor ID
- ZK07
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 1 May 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.
This study is a single-dose, open-label, 2-cycle crossover design, comparing the pharmacokinetic parameters and safety of Inhaled Fentanyl Aerosol and intravenous fentanyl injection.
Detailed description
Consenting patients who met inclusion and exclusion criteria were allowed to enter the study. The subjects will be randomly assigned (1:1) to receive an intravenous bolus (5 seconds) of 25μg fentanyl injection in the first cycle, and after a 2-week washout period, to receive a single dose of 25μg inhaled fentanyl aerosol through the Staccato delivery system in the second cycle; or to receive the same treatment in the opposite order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:Inhaled fentanyl aerosol | Experimental | Drug: Inhaled Fentanyl AerosolSubjects will be randomly assigned (1:1) to either drug sequence |
| Active Comparator:Fentanyl Citrate Injection | Active comparator | Drug: Fentanyl Citrate InjectionSubjects will be randomly assigned (1:1) to either drug sequence |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Volunteer to participate, understand and sign the informed consent form before conducting the evaluation project;
- Male or female subjects, aged between 18 and 55, including 18 and 55 years old;
- Patients with malignant tumors diagnosed by histology or cytology;
- Body Mass Index (BMI) is >21 kg/m2, but <30 kg/m2;
- Have sufficient hematopoietic function and organ function within the last 14 days at random.
Key exclusion criteria (18 listed)
- known or suspected allergy to opioids;
- used opioids within 14 days before the first administration, including but not limited to: codeine, dihydrocodeine, hydromorphone, oxycodone, methadone, morphine, fentanyl and pethidine (pethidine);
- plan to receive radiotherapy and / or systemic chemotherapy within 14 days before the first administration or during the study period (except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable);
- within 14 days before the first administration, the patient had received any monoamine oxidase (MAO) inhibitors (such as phenelzine, isocarbazine, chlorogiline, toloxadone, moclobemide, selegiline, rasagiline, etc.); Or have used CYP3A4 inhibitors (such as indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, nefazodone, ketoconazole, telithromycin, arepitan, erythromycin, fluconazole, grapefruit, verapamil, diltiazem, cimetidine, etc.) or CYP3A4 inducers (such as phenobarbital, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifabutin, rifampicin);
- have participated in other clinical studies or received surgical treatment within 30 days before the screening period, or have surgery plans during the study period;
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 |
|---|---|---|
| Inhaled Fentanyl AerosolThe subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg Fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg Fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order. | Drug | Experimental:Inhaled fentanyl aerosol |
| Fentanyl Citrate InjectionThe subjects will be randomly assigned (1:1) to either dosing sequence: in the first cycle, receive an intravenous bolus (5 seconds) of 25μg fentanyl injection, after at least a 2-week washout period, in the second cycle, receive a single dose of 25μg fentanyl aerosol inhaler through the Staccato delivery system; or receive the same treatment in the reverse order. | Drug | Active Comparator:Fentanyl Citrate Injection |
Primary outcome
Cmax
Time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Peak Concentration
Tmax
Time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Time to Maximum Concentration
Ke
Time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Terminal Elimination Rate
T1/2
Time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Terminal elimination half-life
CL/F
Time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Apparent Clearance (CL/F)
AUC_last
Time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration
AUC_inf
Time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration
Area Under the Concentration-Time Curve from Time Zero to Infinity
1 secondary outcome
Pupil diameter
Time frame: Pupil measurements were taken before administration, and at 1, 2, 3, 5 , 10 , 30minutes , and 1, 2, 4, 8, 12 and 18hours after drug administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
Haiyan Hu, doctor principal investigator
Shanghai 6th People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inhaled Fentanyl Aerosol and Fentanyl Citrate Injection in people with Cancer, run by Lee's Pharmaceutical Limited at 2 sites 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 14 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Hu, doctor (+86 18930174575, xurill@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Before administration (within 30 minutes), 15 seconds , 30 seconds, 45 seconds, 90 seconds, 3 minutes, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 18 hours after administration). The study lists 7 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 25 Sep 2025.