HealthyPhase 1NCT06918366
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled XQ-001 in Healthy Subjects
A Phase 1 study testing Part A - single rising dose 1, Part A - single rising dose 2 and Part A - single rising dose 3 in people with Healthy, run by Brilliant Inspiration Biotherapeutics at 1 site in China.
Trial summary
The primary study objective is to evaluate the safety and tolerability of XQ-001 for inhalation after single and multiple nebulized inhalation administration in healthy Chinese adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Part A - single rising dose 1, Part A - single rising dose 2 and Part A - single rising dose 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 May 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Healthy adult male or female subjects aged 18-45 years old (including the boundary value, based on the time of signing the informed consent form) at the time of screening;
- 2) Body mass index (BMI: weight [kg]/height [m]2) is between 18.0 and 28.0 kg/m2 (inclusive), male subjects weigh ≥50 kg, and female subjects weigh ≥45 kg;
- 3) Normal lung function during the screening period, i.e., FEV1 ≥ 80% predicted and FEV1/FVC > 92% predicted;
- 4) During the screening period, the subjects' vital signs, physical examinations, laboratory tests, 12-lead electrocardiogram (ECG) and chest X-ray showed no abnormalities or abnormalities without clinical significance;
- 5) Qualified subjects of fertile potential must agree to use a medically approved contraceptive measure (such as intrauterine contraceptive device, contraceptive pills or condoms) during the trial and within 6 months after the trial. Specific contraceptive measures are shown in Appendix 1; and have no plans to donate sperm/eggs during the trial and within 6 months after the trial;
- 6) Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily participate and sign a written informed consent form, and can complete the study in accordance with the requirements of the protocol.
Who cannot join
- 1) Known severe allergic, non-allergic drug reaction, or multiple drug allergies, or known hypersensitivity reaction to the investigational product (active drug substance or drug product excipients);
- 2) The presence of symptoms or related medical history of any major disease, including but not limited to heart, liver, kidney disease or other acute or chronic gastrointestinal diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, neurological, mental and other systemic diseases, or any other disease or physiological condition that may interfere with the results of the trial; any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or difficulty urinating, peptic tract ulcer, history of gastrointestinal bleeding, etc;
- 3) Those who have been diagnosed with or are currently suffering from bronchial asthma, airway hyperresponsiveness, or have history of suspected asthma attacks;
- 4) Current chronic liver disease or a known history of liver or biliary abnormalities that the investigator determines may affect the trial results; liver function test results at screening are outside the normal range of the research center and are determined by the investigator to be abnormal and clinically significant (two replicate assessments are allowed at the investigator's discretion);
- 5) Current arrhythmia diseases (symptomatic or asymptomatic) or a history of arrhythmia determined by the investigator to be abnormal and clinically significant;
- 6) Clinically significant ECG abnormalities, including but not limited to second or third degree atrioventricular block, QRS complex prolongation of more than 120 msec, or QTc interval prolongation (QTcF>450 msec for male subjects and QTcF>470 msec for female subjects, see Appendix 2 for the formula);
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- 7) Heart rate <50 or >100 beats/minute at screening, and determined by the investigator to be abnormal and clinically significant;
- 8) Severe infection occurred within 30 days before the first administration, including cellulitis, infectious pneumonia, sepsis, etc. For subjects with mild infection (such as mild upper respiratory tract infection), the investigator can determine whether they are suitable for inclusion;
- 9) Received live vaccination within 30 days before the first dose;
- 10) Suffered from a major clinically significant disease or underwent major surgery within 3 months before the first dose (except for outpatient minor surgeries), or expected to need major surgery during the trial;
- 11) Those with a known or suspected history of drug abuse within 2 years before screening, or drug abuse within 3 months before screening, or positive drug abuse screening during the screening period and baseline period;
- 12) Those who have used clinical trial drugs within 3 months before the first dose, or plan to participate in other interventional clinical trials during this study;
- 13) Those who have used any prescription drugs (including drugs that induce and inhibit liver drug enzymes), over-the-counter drugs, Chinese herbal medicines, and health products within 14 days before the first dose (or within 7 half-lives, whichever is the longest);
- 14) Those who donated blood or lost blood ≥400 mL within 3 months before screening; or donated blood or lost blood ≥200 mL within 1 month before screening; or planned to donate blood during the study;
- 15) Those who used food or beverages that may affect liver metabolism (such as star fruit, pomelo, grapefruit, etc.) within 7 days before the first dose;
- 16) Those who habitually use nicotine products or smoke (more than 5 cigarettes per day) within 3 months before screening, or those who do not agree to refrain from smoking or using nicotine products during the trial;
- 17) Drink more than 14 units of alcohol per week within 6 months before screening (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol by volume liquor or 150 mL of wine); or those who have a positive alcohol breath test during the baseline period; or those who do not agree to refrain from taking any alcoholic products during the trial;
- 18) Those who are unwilling to refrain from caffeinated beverages from 24 hours before the first dose until the end of this study;
- 19) Positive human immunodeficiency virus (HIV) antibody, or positive hepatitis B surface antigen, or positive hepatitis C antibody, or positive syphilis spirochete antibody;
- 20) Malignant tumor within 5 years before screening (excluding resected and cured carcinoma in situ, such as non-malignant melanoma skin cancer, etc.);
- 21) Pregnant or lactating women, or those with a positive pregnancy test during the screening period or hospitalization examination;
- 22) The investigator believes that it is not appropriate to participate in this study for scientific reasons, compliance reasons, or subject safety reasons;
- 23) Those who have previously used XQ-001 for inhalation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of XQ-001 for Inhalation in Healthy Subjects
The primary study objective is to evaluate the safety and tolerability of XQ-001 for inhalation after single and multiple nebulized inhalation administration in healthy Chinese adult subjects.
- Conditions
- Healthy
- Being tested
- Part A - single rising dose 1, Part A - single rising dose 2, Part A - single rising dose 3, Part A - single rising dose 4, Part A - single rising dose 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A - single rising dose 1Drug
Also called Single dose 1
Inhaled XQ-001
Part A - single rising dose 2Drug
Also called Single dose 2
Inhaled XQ-001 or Placebo
Part A - single rising dose 3Drug
Also called Single dose 3
Inhaled XQ-001 or Placebo
Part A - single rising dose 4Drug
Also called Single dose 4
Inhaled XQ-001 or Placebo
Part A - single rising dose 5Drug
Also called Single dose 5
Inhaled XQ-001 or Placebo
Part A - single rising dose 6Drug
Also called Single dose 6
Inhaled XQ-001 or Placebo
Part B - mutiple rising dose 1Drug
Also called Mutiple dose 1
Inhaled XQ-001 or Placebo
Part B - mutiple rising dose 2Drug
Also called Mutiple dose 2
Inhaled XQ-001 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A - single rising dose 1 | Other | inhalation Receives: Drug: Part A - single rising dose 1 |
| Part A - single rising dose 2 | Other | inhalation Receives: Drug: Part A - single rising dose 2 |
| Part A - single rising dose 3 | Other | inhalation Receives: Drug: Part A - single rising dose 3 |
| Part A - single rising dose 4 | Other | inhalation Receives: Drug: Part A - single rising dose 4 |
| Part A - single rising dose 5 | Other | inhalation Receives: Drug: Part A - single rising dose 5 |
| Part A - single rising dose 6 | Other | inhalation Receives: Drug: Part A - single rising dose 6 |
| Part B - multiple rising dose 1 | Other | inhalation Receives: Drug: Part B - mutiple rising dose 1 |
| Part B - multiple rising dose 2 | Other | inhalation Receives: Drug: Part B - mutiple rising dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (%) of participants experiencing adverse events (AE) and serious adverse events (SAE)
Measured: Up to 9 days
Number (%) of participants with clinically relevant changes in 12-lead ECGs, vital signs, clinical laboratory parameters, physical examinations, or pulmonary function test
Measured: Up to 9 days
Secondary outcomes (3)
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: Up to 24 hours after first and last dose
Time of maximum observed concentration (Tmax)
Measured: Up to 24 hours after first and last dose
Area under the plasma concentration-time curve (AUC) from time 0 to time t, where t is the last time point at which the concentration is above the lower limit of quantification (AUC0-t)
Measured: Up to 24 hours after first and last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Aug 2024
- Primary completion31 Mar 2025
- Study completion30 May 2025 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brilliant Inspiration Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918366
- Sponsor's protocol ID
- XQ-2023CT-001-01
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of XQ-001 for Inhalation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06918366
- Acronym / sponsor ID
- XQ-2023CT-001-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Brilliant Inspiration BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objective is to evaluate the safety and tolerability of XQ-001 for inhalation after single and multiple nebulized inhalation administration in healthy Chinese adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A - single rising dose 1 | Other | Drug: Part A - single rising dose 1inhalation |
| Part A - single rising dose 2 | Other | Drug: Part A - single rising dose 2inhalation |
| Part A - single rising dose 3 | Other | Drug: Part A - single rising dose 3inhalation |
| Part A - single rising dose 4 | Other | Drug: Part A - single rising dose 4inhalation |
| Part A - single rising dose 5 | Other | Drug: Part A - single rising dose 5inhalation |
| Part A - single rising dose 6 | Other | Drug: Part A - single rising dose 6inhalation |
| Part B - multiple rising dose 1 | Other | Drug: Part B - mutiple rising dose 1inhalation |
| Part B - multiple rising dose 2 | Other | Drug: Part B - mutiple rising dose 2inhalation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1) Healthy adult male or female subjects aged 18-45 years old (including the boundary value, based on the time of signing the informed consent form) at the time of screening;
- 2) Body mass index (BMI: weight [kg]/height [m]2) is between 18.0 and 28.0 kg/m2 (inclusive), male subjects weigh ≥50 kg, and female subjects weigh ≥45 kg;
- 3) Normal lung function during the screening period, i.e., FEV1 ≥ 80% predicted and FEV1/FVC > 92% predicted;
- 4) During the screening period, the subjects' vital signs, physical examinations, laboratory tests, 12-lead electrocardiogram (ECG) and chest X-ray showed no abnormalities or abnormalities without clinical significance;
- 5) Qualified subjects of fertile potential must agree to use a medically approved contraceptive measure (such as intrauterine contraceptive device, contraceptive pills or condoms) during the trial and within 6 months after the trial. Specific contraceptive measures are shown in Appendix 1; and have no plans to donate sperm/eggs during the trial and within 6 months after the trial;
Key exclusion criteria (23 listed)
- 1) Known severe allergic, non-allergic drug reaction, or multiple drug allergies, or known hypersensitivity reaction to the investigational product (active drug substance or drug product excipients);
- 2) The presence of symptoms or related medical history of any major disease, including but not limited to heart, liver, kidney disease or other acute or chronic gastrointestinal diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, neurological, mental and other systemic diseases, or any other disease or physiological condition that may interfere with the results of the trial; any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or difficulty urinating, peptic tract ulcer, history of gastrointestinal bleeding, etc;
- 3) Those who have been diagnosed with or are currently suffering from bronchial asthma, airway hyperresponsiveness, or have history of suspected asthma attacks;
- 4) Current chronic liver disease or a known history of liver or biliary abnormalities that the investigator determines may affect the trial results; liver function test results at screening are outside the normal range of the research center and are determined by the investigator to be abnormal and clinically significant (two replicate assessments are allowed at the investigator's discretion);
- 5) Current arrhythmia diseases (symptomatic or asymptomatic) or a history of arrhythmia determined by the investigator to be abnormal and clinically significant;
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 |
|---|---|---|
| Part A - single rising dose 1Also: Single dose 1Inhaled XQ-001 | Drug | Part A - single rising dose 1 |
| Part A - single rising dose 2Also: Single dose 2Inhaled XQ-001 or Placebo | Drug | Part A - single rising dose 2 |
| Part A - single rising dose 3Also: Single dose 3Inhaled XQ-001 or Placebo | Drug | Part A - single rising dose 3 |
| Part A - single rising dose 4Also: Single dose 4Inhaled XQ-001 or Placebo | Drug | Part A - single rising dose 4 |
| Part A - single rising dose 5Also: Single dose 5Inhaled XQ-001 or Placebo | Drug | Part A - single rising dose 5 |
| Part A - single rising dose 6Also: Single dose 6Inhaled XQ-001 or Placebo | Drug | Part A - single rising dose 6 |
| Part B - mutiple rising dose 1Also: Mutiple dose 1Inhaled XQ-001 or Placebo | Drug | Part B - multiple rising dose 1 |
| Part B - mutiple rising dose 2Also: Mutiple dose 2Inhaled XQ-001 or Placebo | Drug | Part B - multiple rising dose 2 |
Primary outcome
Number (%) of participants experiencing adverse events (AE) and serious adverse events (SAE)
Time frame: Up to 9 days
Number (%) of participants with clinically relevant changes in 12-lead ECGs, vital signs, clinical laboratory parameters, physical examinations, or pulmonary function test
Time frame: Up to 9 days
3 secondary outcomes
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 24 hours after first and last dose
Time of maximum observed concentration (Tmax)
Time frame: Up to 24 hours after first and last dose
Area under the plasma concentration-time curve (AUC) from time 0 to time t, where t is the last time point at which the concentration is above the lower limit of quantification (AUC0-t)
Time frame: Up to 24 hours after first and last dose
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 10 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Part A - single rising dose 1, Part A - single rising dose 2 and Part A - single rising dose 3 in people with Healthy, run by Brilliant Inspiration Biotherapeutics 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 6 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
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 participants experiencing adverse events (AE) and serious adverse events (SAE) (time frame: Up to 9 days). The study lists 2 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 10 Apr 2025.