HealthyPhase 1NCT05034120
Food Effect and Mass Balance Study of XZP-3621 Tablets
A Phase 1 study testing XZP-3621 in people with Healthy, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- XZP-3621
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2021to 30 Mar 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
- Subject who meet all of the requirements as follows will be included.
- Healthy male or female subjects aged 18 to 65 (including 18 and 65);
- Male weight ≥50 kg, female weight ≥45 kg, body mass index in the range of 18-28 kg/m2 (including 18 and 28);
- No medical history of mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
- Subjects agree to use effective contraceptive methods, such as condoms, contraceptive sponges, contraceptive gels, contraceptive membrane, intrauterine device, oral or injectable contraceptives, subcutaneous implants, or other contraceptive methods, from screening (2 weeks prior to screening for female subjects) to 6 months after the last dose;
- The subject can have a good communication with the investigators, understand and comply with the requirements of this study, understand and sign the informed consent voluntarily.
Who cannot join
- Subject who meet either of the requirements as follows will be excluded.
- Hypersensitivity (hypersensitivity to two or more substances) or known hypersensitivity to XZP-3621 tablets/similar drugs;
- Abnormal examination during the screening period with clinical significance (to be determined by the investigator);
- Frequent use of sedatives、sleeping pills or other addictive drugs et al;
- Those who had a history of drug abuse or urine drug abuse screening positive within 12 months before enrollment;
- Smoking more than 5 cigarettes a day, or failing to stop using any tobacco products during the test period;
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- Positive breath test for alcohol or regular drinkers in the 6 months prior to entry, i.e. drinking more than 3 units per day or more than 21 units per week (one unit is equivalent to a 350 mL bottle of beer or 120 mL of liquor or 30 mL of spirits (over 50°));
- Take any prescription medicine or Chinese herbal medicine within 4 weeks before enrollment, and/or Take any over-the-counter (OTC) drug or food supplement (including vitamins, calcium tablets and other health care products) within 2 weeks before the first administration of XZP-3621 tablet;
- Those who have participated in other clinical trials and taken experimental drugs within 3 months before enrollment;
- Blood donation (including component blood donation) or blood loss of 400 mL within 3 months before enrollment, or blood transfusion;Blood donation (including component blood donation) or blood loss of 200 mL within 1 month before the test;
- Have a history of major disease or major surgery or trauma 3 months before screening;
- A history of gastrointestinal disease causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or a history of severe vomiting or diarrhea within the week prior to enrollment;
- Female subjects during pregnancy and lactation and female subjects of childbearing age who cannot use contraception as required;
- Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
- Have special dietary requirements (including lactose intolerance) and fail to comply with the provided diet and corresponding regulations;
- Subjects who are Dysphagia;
- Subjects who refuse to stop any beverage or food containing methylxanthine, such as caffeine (coffee, tea, cola, chocolate, grapefruit and beverages containing this ingredient, etc.) 48 hours prior to first administration of XZP-3621 tablets until the end of the study.
- Subjects who will refuse to discontinue any CYP3A4 inhibitors and inducers judged by the investigator within 7 days prior to the first administration of XZP-3621 tablets or within 5 half-lives of CYP3A4 inhibitors and inducers (whichever is longer) until the end of the study;
- Subjects who are Inability to tolerate venipuncture or poor vascular status;
- Subjects who are unsuitable to participate in this study judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Food Effect on the Pharmacokinetics of XZP-3621 Tablets and the Absorption, Metabolism and Excretion of XZP-3621 in Chinese Healthy Volunteers
This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects. The stage 2 is to evaluate the effect of food on the Pharmacokinetics of single-dose XZP-3621 tablets in Chinese Healthy Volunteers. In addition, the safety of XZP-3621 tablets in Chinese Healthy Volunteers will also be evaluated.
Read the detailed description
Stage 1: 10 healthy adult subjects will be included in the study. Excretion (feces, urine) and vomit samples will be collected daily and tested for prototype drug and metabolites of XZP-3621, the metabolites will be identified in all substrates except vomits pose-dose of 400 mg XZP-3621 tablets.
Vomit samples collection: Time interval for subject vomit collection (if any) (planned):0~4 h,4~8 h,8~12 h,12~24 h,24~48 h,48~72 h,72~96 h,96~120 h,120~144 h,144~168 h,168~192 h after taking single XZP-3621 tablet. Samples of all vomits during that time interval will be collected at each time interval after taking single XZP-3621 tablet.
Urine samples collection: Time interval for sample collection(planned):24h before taking single XZP-3621 tablet,0~4 h,4~8 h,8~12 h,12~24 h,24~48 h,48~72 h,72~96 h,96~120 h,120~144 h,144~168 h,168~192 h after taking single XZP-3621 tablet, Urine samples were collected from each subject at a total of 12 time intervals (Only one urine sample should be collected within 24 hours before taking single XZP-3621 tablet), Urine volume was accurately recorded for each time period.
Feces samples collection: Interval of fecal sample collection of subjects (planned):24h before taking single XZP-3621 tablet,0~24 h,24~48 h,48~72 h,72~96 h,96~120 h,120~144 h,144~168 h,168~192 h after taking single XZP-3621 tablet. Feces samples will be collected from each subject at a total of 9 time intervals (Only one sample was collected within 24 h before taking single XZP-3621 tablet), And accurate fecal weight will be recorded for each time period.
PK blood sample collection: PK blood samples of subjects will be collected before administration (within 2 h before administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after administration at 18 collection points. Plasma samples for metabolite identification should be separately packaged.
Stage 2: This stage of study will be a randomized, open, three-cycle crossover study to evaluate the pharmacokinetic effects and safety of a single oral dose of XZP-3621 in healthy subjects on a high-fat diet versus a standard diet.
In this study stage, 24 healthy subjects meeting the requirements of the protocol will be planned to be enrolled and randomly divided into groups A, B, C, D, E and F at 1:1:1:1:1:1 , with 4 subjects in each group. Each subject will undergo three cycles of fasting administration, high-fat postprandial administration, and standard postprandial administration (in random order) throughout the study.
PK blood sample collection: PK blood samples will be collected before taking single XZP-3621 tablet (within 2 h before drug administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after taking single XZP-3621 tablet in each cycle, with a total of 18 collection points.
- Conditions
- Healthy
- Being tested
- XZP-3621
- Keywords
- XZP-3621, Food-Effect, Mass Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XZP-3621Drug
Administer a single dose of XZP-3621 tablet after a low-fat meal.
XZP-3621Drug
Cycle1(D1-D9): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
XZP-3621Drug
Cycle1(D1-D9) : Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after on an empty stomach in a single dose on Day19.
XZP-3621Drug
Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
XZP-3621Drug
Cycle1(D1-D9) : Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
XZP-3621Drug
Cycle1(D1-D9): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
XZP-3621Drug
Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day19.
| Study group | Role | What they receive |
|---|---|---|
| MB:Single arm | Experimental | 10 subjects will be enrolled in this arm. The subjects will take a single dose XZP-3621 tablet after a low-fat meal and perform excretion collection consistently. Receives: Drug: XZP-3621 |
| FE:Arm A | Experimental | Cycle1 Day1: fasting; Cycle2 Day10: High-fat meal; Cycle3 Day19: Low-fat meal Receives: Drug: XZP-3621 |
| FE:Arm B | Experimental | Cycle1 Day1: High-fat meal; Cycle2 Day10: Low-fat meal; Cycle3 Day19: fasting Receives: Drug: XZP-3621 |
| FE:Arm C | Experimental | Cycle1 Day1: Low-fat meal; Cycle2 Day10: fasting; Cycle3 Day19: High-fat meal Receives: Drug: XZP-3621 |
| FE:Arm D | Experimental | Cycle1 Day1: fasting; Cycle2 Day10: Low-fat meal; Cycle3 Day19: High-fat meal Receives: Drug: XZP-3621 |
| FE:Arm E | Experimental | Cycle1 Day1: High-fat meal; Cycle2 Day10: fasting; Cycle3 Day19: Low-fat meal Receives: Drug: XZP-3621 |
| FE:Arm F | Experimental | Cycle1 Day1: Low-fat meal; Cycle2 Day10: High-fat meal; Cycle3 Day19:fasting Receives: Drug: XZP-3621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t(area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
Measured: up to 192 hours
Cmax(maximum measured concentration of the analyte in plasma)
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
Measured: up to 192 hours
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
Measured: up to 192 hours
to determine the Mass Balance recovery of orally administered XZP-3621 and its metabolites in all (urine, faeces and vomits) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
cumulative excretions after a single dose of XZP-3621 and its metabolites in urine, feces and vomits.
Measured: MB stage:Day1-Day9
Secondary outcomes (3)
Tmax(the time from dosing at which Cmax was apparent)
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
Measured: up to 192 hours
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
Measured: MB Stage:28±3 days,FE Stage:47±3 days
T1/2(Apparent terminal elimination half-life )
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
Measured: up to 192 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start23 Dec 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
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.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034120
- Sponsor's protocol ID
- XZP-3621-1002
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 25 May 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Food Effect on the Pharmacokinetics of XZP-3621 Tablets and the Absorption, Metabolism and Excretion of XZP-3621 in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05034120
- Acronym / sponsor ID
- XZP-3621-1002
- Conditions
- Healthy
- Keywords
- XZP-3621, Food-Effect, Mass Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 5 Sep 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.
This is a single-center, open-label, single-dose phase I study, the study is divided into two stages. The stage 1 is to investigate the absorption, metabolism and excretion of XZP-3621 tablets in healthy Chinese subjects. The stage 2 is to evaluate the effect of food on the Pharmacokinetics of single-dose XZP-3621 tablets in Chinese Healthy Volunteers. In addition, the safety of XZP-3621 tablets in Chinese Healthy Volunteers will also be evaluated.
Detailed description
Stage 1: 10 healthy adult subjects will be included in the study. Excretion (feces, urine) and vomit samples will be collected daily and tested for prototype drug and metabolites of XZP-3621, the metabolites will be identified in all substrates except vomits pose-dose of 400 mg XZP-3621 tablets.
Vomit samples collection: Time interval for subject vomit collection (if any) (planned):0~4 h,4~8 h,8~12 h,12~24 h,24~48 h,48~72 h,72~96 h,96~120 h,120~144 h,144~168 h,168~192 h after taking single XZP-3621 tablet. Samples of all vomits during that time interval will be collected at each time interval after taking single XZP-3621 tablet.
Urine samples collection: Time interval for sample collection(planned):24h before taking single XZP-3621 tablet,0~4 h,4~8 h,8~12 h,12~24 h,24~48 h,48~72 h,72~96 h,96~120 h,120~144 h,144~168 h,168~192 h after taking single XZP-3621 tablet, Urine samples were collected from each subject at a total of 12 time intervals (Only one urine sample should be collected within 24 hours before taking single XZP-3621 tablet), Urine volume was accurately recorded for each time period.
Feces samples collection: Interval of fecal sample collection of subjects (planned):24h before taking single XZP-3621 tablet,0~24 h,24~48 h,48~72 h,72~96 h,96~120 h,120~144 h,144~168 h,168~192 h after taking single XZP-3621 tablet. Feces samples will be collected from each subject at a total of 9 time intervals (Only one sample was collected within 24 h before taking single XZP-3621 tablet), And accurate fecal weight will be recorded for each time period.
PK blood sample collection: PK blood samples of subjects will be collected before administration (within 2 h before administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after administration at 18 collection points. Plasma samples for metabolite identification should be separately packaged.
Stage 2: This stage of study will be a randomized, open, three-cycle crossover study to evaluate the pharmacokinetic effects and safety of a single oral dose of XZP-3621 in healthy subjects on a high-fat diet versus a standard diet.
In this study stage, 24 healthy subjects meeting the requirements of the protocol will be planned to be enrolled and randomly divided into groups A, B, C, D, E and F at 1:1:1:1:1:1 , with 4 subjects in each group. Each subject will undergo three cycles of fasting administration, high-fat postprandial administration, and standard postprandial administration (in random order) throughout the study.
PK blood sample collection: PK blood samples will be collected before taking single XZP-3621 tablet (within 2 h before drug administration) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192 h after taking single XZP-3621 tablet in each cycle, with a total of 18 collection points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| MB:Single arm | Experimental | Drug: XZP-362110 subjects will be enrolled in this arm. The subjects will take a single dose XZP-3621 tablet after a low-fat meal and perform excretion collection consistently. |
| FE:Arm A | Experimental | Drug: XZP-3621Cycle1 Day1: fasting; Cycle2 Day10: High-fat meal; Cycle3 Day19: Low-fat meal |
| FE:Arm B | Experimental | Drug: XZP-3621Cycle1 Day1: High-fat meal; Cycle2 Day10: Low-fat meal; Cycle3 Day19: fasting |
| FE:Arm C | Experimental | Drug: XZP-3621Cycle1 Day1: Low-fat meal; Cycle2 Day10: fasting; Cycle3 Day19: High-fat meal |
| FE:Arm D | Experimental | Drug: XZP-3621Cycle1 Day1: fasting; Cycle2 Day10: Low-fat meal; Cycle3 Day19: High-fat meal |
| FE:Arm E | Experimental | Drug: XZP-3621Cycle1 Day1: High-fat meal; Cycle2 Day10: fasting; Cycle3 Day19: Low-fat meal |
| FE:Arm F | Experimental | Drug: XZP-3621Cycle1 Day1: Low-fat meal; Cycle2 Day10: High-fat meal; Cycle3 Day19:fasting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject who meet all of the requirements as follows will be included.
Key exclusion criteria (20 listed)
- Subject who meet either of the requirements as follows will be excluded.
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 |
|---|---|---|
| XZP-3621Administer a single dose of XZP-3621 tablet after a low-fat meal. | Drug | MB:Single arm |
| XZP-3621Cycle1(D1-D9): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19. | Drug | FE:Arm A |
| XZP-3621Cycle1(D1-D9) : Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after on an empty stomach in a single dose on Day19. | Drug | FE:Arm B |
| XZP-3621Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19. | Drug | FE:Arm C |
| XZP-3621Cycle1(D1-D9) : Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19. | Drug | FE:Arm D |
| XZP-3621Cycle1(D1-D9): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19. | Drug | FE:Arm E |
| XZP-3621Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day19. | Drug | FE:Arm F |
Primary outcome
AUC0-t(area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 192 hours
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
Cmax(maximum measured concentration of the analyte in plasma)
Time frame: up to 192 hours
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 192 hours
Pharmacokinetic Data Analysis for XZP-3621 and its metabolites
to determine the Mass Balance recovery of orally administered XZP-3621 and its metabolites in all (urine, faeces and vomits) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
Time frame: MB stage:Day1-Day9
cumulative excretions after a single dose of XZP-3621 and its metabolites in urine, feces and vomits.
3 secondary outcomes
Tmax(the time from dosing at which Cmax was apparent)
Time frame: up to 192 hours
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: MB Stage:28±3 days,FE Stage:47±3 days
T1/2(Apparent terminal elimination half-life )
Time frame: up to 192 hours
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 25 May 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.
Yu Cao principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XZP-3621 in people with Healthy, run by Xuanzhu Biopharmaceutical Co., Ltd. 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 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t(area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) (time frame: up to 192 hours). 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 25 May 2025.