Healthy ParticipantsPhase 1NCT07923578
Pharmacokinetics, Safety and Tolerability of Single Sequential and Multiple Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants
A Phase 1 study testing Ulinastatin in people with Healthy Participants and Ulinastatin, run by Techpool Bio-Pharma Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 1 clinical study. The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ulinastatin for injection after single sequential and multiple continuous intravenous infusions in healthy Chinese volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Ulinastatin
- What is being tested?
- Ulinastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Jun 2027
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be enrolled:
- Healthy Chinese male or female participants, as confirmed by medical history, physical examination, vital signs, 12-lead ECG, chest X-ray, and laboratory tests at screening.
- Age 18 to 55 years, inclusive.
- Body mass index (BMI) 19.0 to 28.0 kg/m2, inclusive; body weight at least 45.0 kg for women and at least 50.0 kg for men.
- Able to understand the procedures and methods of the study, willing to comply strictly with the protocol, and able to provide written informed consent.
Who cannot join
- Participants meeting any of the following criteria are not eligible for enrollment:
- Smoking more than 5 cigarettes per day within 3 months before screening, or unable to abstain from smoking from 48 hours before dosing through the study period.
- Alcohol intake exceeding 14 units per week within 3 months before screening (1 unit = 360 mL of beer, 45 mL of spirits containing 40% alcohol, or 150 mL of wine), or consumption of alcohol-containing products within 48 hours before the first dose, or unable to abstain from alcohol during the study, or a positive blood alcohol test at screening or at admission (Day -2).
- History of drug abuse within 6 months before screening.
- History or presence of severe cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- History of malignancy of any organ system within 5 years before screening, whether treated or untreated, and regardless of evidence of local recurrence or metastasis.
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- History of clinically significant electrocardiographic abnormalities.
- History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurologic disorders that may alter the absorption, metabolism, or elimination of drugs.
- Clinically significant abnormalities in laboratory tests at screening.
- History or evidence of renal impairment, manifested as clinically significant abnormalities in creatinine, blood urea nitrogen, or urea, or abnormal urine composition (e.g., proteinuria).
- Severe illness, severe infection, or trauma within 2 weeks before dosing.
- Blood donation of 400 mL or more within 3 months before dosing, or significant blood loss of at least 400 mL.
- Allergic constitution, history of drug or food allergy, or known hypersensitivity to the study drug or to components of similar drugs.
- Participation in any other clinical trial and receipt of an investigational drug or device within 3 months before dosing.
- Use of prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (including vitamins), or any drug that may interfere with the interpretation of safety data, or any drug or herbal medicine with known common toxicity to major organs, within 2 weeks before dosing.
- Surgery within 3 months before the first dose, or planned surgery during the study period.
- Pregnant or lactating women, or men or women of reproductive potential who are unwilling to use effective contraception from the start of the study through 90 days after dosing.
- Positive test for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
- Difficulty with intravenous administration or blood sampling, or history of needle phobia or hematophobia.
- Any other condition that, in the opinion of the investigator, may prevent the participant from completing the study or may place the participant at significant risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Wei Hu, 0551-63869420, hwgcp@ayefy.com
About this study
Official title: A Placebo-Controlled, Double-Blind, Phase I Clinical Study to Evaluate Pharmacokinetic Characteristics, Safety and Tolerability of Single Sequential and Multiple Continuous Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants
This is a Phase 1 clinical study. The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ulinastatin for injection after single sequential and multiple continuous intravenous infusions in healthy Chinese volunteers.
Key study questions:
- - How does ulinastatin behave in the body after single sequential and multiple continuous intravenous infusions?
- - What are the safety outcomes and side effects in healthy people receiving this investigational drug?
- Study participants will:
- - Complete screening assessments to check if they meet the study requirements.
- - Receive either ulinastatin for injection or placebo (inactive substance with no study drug) via intravenous drip.
- - Follow the study schedule for single sequential infusions and multiple continuous infusions.
- - Provide blood samples to measure drug concentration in the body.
- - Undergo safety evaluations including physical examinations, vital sign monitoring and laboratory tests throughout the study period.
- The study will compare data from participants receiving the study drug versus those receiving placebo to assess drug-related exposure and adverse reactions.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled Phase 1 study of ulinastatin for injection in healthy Chinese adults. Approximately 40 participants will be enrolled sequentially into 4 cohorts and randomized 8:2 to ulinastatin or placebo, to evaluate single ascending doses of 100,000 to 8,000,000 units and multiple ascending doses of 400,000 or 1,600,000 units administered three times daily for 4 consecutive days. Serial blood samples will be collected for non-compartmental pharmacokinetic analysis, and safety and tolerability will be assessed throughout the study.
- Conditions
- Healthy Participants, Ulinastatin
- Being tested
- Ulinastatin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Name Ulinastatin for injection
Type Drug
Other Names Ulinastatin; UTI
Lyophilized powder for injection, 100,000 units per vial; white to slightly yellow lyophilized cake or powder. Reconstituted and diluted in 250 mL of 5% glucose injection, then administered by intravenous infusion over 2 hours (±5 minutes). Single doses of 100,000 to 8,000,000 units were administered in the single-ascending-dose cohorts; doses of 400,000 or 1,600,000 units were administered three times daily for 4 consecutive days in the multiple-ascending-dose cohorts. Manufactured by Guangdong Techpool Biochemical Pharmaceutical Co., Ltd.
PlaceboDrug
Name Placebo
Type Drug
Other Names 5% glucose injection
250 mL of 5% glucose injection, prepared and administered so as to be indistinguishable in appearance from the reconstituted study drug. Contains no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Ulinastatin single ascending dose (100,000, 2,000,000, and 6,000,000 units) | Experimental | Participants receive a single 2-hour intravenous infusion of ulinastatin 100,000 units on Day 1, 2,000,000 units on Day 4, and 6,000,000 units on Day 7. Receives: Drug: Ulinastatin |
| Cohort 1: Placebo | Placebo comparator | Participants receive a single 2-hour intravenous infusion of placebo (5% glucose injection) on Days 1, 4, and 7, matching the ulinastatin schedule in Cohort 1. Receives: Drug: Placebo |
| Cohort 2: Ulinastatin single ascending dose (1,000,000, 4,000,000, and 8,000,000 units) | Experimental | Participants receive a single 2-hour intravenous infusion of ulinastatin 1,000,000 units on Day 1, 4,000,000 units on Day 4, and 8,000,000 units on Day 7. Receives: Drug: Ulinastatin |
| Cohort 2: Placebo | Placebo comparator | Participants receive a single 2-hour intravenous infusion of placebo (5% glucose injection) on Days 1, 4, and 7, matching the ulinastatin schedule in Cohort 2. Receives: Drug: Placebo |
| Cohort 3: Ulinastatin multiple ascending dose (400,000 units three times daily for 4 days) | Experimental | Participants receive 2-hour intravenous infusions of ulinastatin 400,000 units three times daily (at 8:00, 16:00, and 23:00, ±1 hour) on Days 1 to 3, and one morning dose on Day 4 (last dose). Receives: Drug: Ulinastatin |
| Cohort 3: Placebo | Placebo comparator | Participants receive infusions of placebo (5% glucose injection) three times daily on Days 1 to 3 and one morning dose on Day 4, matching the ulinastatin schedule in Cohort 3. Receives: Drug: Placebo |
| Cohort 4: Ulinastatin multiple ascending dose (1,600,000 units three times daily for 4 days) | Experimental | Participants receive 2-hour intravenous infusions of ulinastatin 1,600,000 units three times daily (at 8:00, 16:00, and 23:00, ±1 hour) on Days 1 to 3, and one morning dose on Day 4 (last dose). Receives: Drug: Ulinastatin |
| Cohort 4: Placebo | Placebo comparator | Participants receive infusions of placebo (5% glucose injection) three times daily on Days 1 to 3 and one morning dose on Day 4, matching the ulinastatin schedule in Cohort 4. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration(Cmax)
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Measured: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Area under the plasma concentration-time curve from time zero to the last quantifiable
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Measured: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Measured: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Time to reach peak plasma concentration (Tmax)
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Measured: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Terminal elimination half-life (t1/2)
Measured: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Apparent clearance (CL)
Measured: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Apparent volume of distribution (Vz)
Measured: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Peak plasma concentration at steady state (Cmax,ss)
Measured: Up to 24 hours after the start of the Day 4 infusion (last dose)
Trough plasma concentration at steady state (Cmin,ss)
Measured: Predose on Day 4
Time to reach peak plasma concentration at steady state (Tmax,ss)
Measured: Up to 24 hours after the start of the Day 4 infusion (last dose)
Area under the plasma concentration-time curve during a dosing interval at steady state (AUC0-tau,ss)
Measured: Up to 24 hours after the start of the Day 4 infusion (last dose)
Accumulation ratio based on Cmax and AUC0-tau (Rac)
Measured: Up to 24 hours after the start of the Day 4 infusion (last dose)
Secondary outcomes (1)
Incidence and severity of adverse events (AEs)
Measured: From the first dose up to 7 days (±1 day) after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants are enrolled sequentially into 4 cohorts. Cohorts 1 and 2 are single-ascending-dose cohorts, in which each participant receives 3 sequential single doses on Days 1, 4, and 7. Cohorts 3 and 4 are multiple-ascending-dose cohorts, in which each participant receives three infusions daily for 4 consecutive days. Cohorts are enrolled in ascending dose order, with an interval of at least 2 weeks between cohorts; initiation of the next cohort is based on review of available safety data from the preceding cohort(s). Within each cohort, participants are randomized in an 8:2 ratio to ulinastatin or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923578
- Sponsor's protocol ID
- HJG-WSTD-GDTP
- Status last verified
- Nov 2026
- First submitted
- 21 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The data are proprietary to the sponsor and are not made available to external parties.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind, Phase I Clinical Study to Evaluate Pharmacokinetic Characteristics, Safety and Tolerability of Single Sequential and Multiple Continuous Intravenous Infusions of Ulinastatin for Injection in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07923578
- Acronym / sponsor ID
- HJG-WSTD-GDTP
- Conditions
- Healthy Participants, Ulinastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Nov 2026 (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 Phase 1 clinical study. The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ulinastatin for injection after single sequential and multiple continuous intravenous infusions in healthy Chinese volunteers.
Key study questions:
- - How does ulinastatin behave in the body after single sequential and multiple continuous intravenous infusions?
- - What are the safety outcomes and side effects in healthy people receiving this investigational drug?
- Study participants will:
- - Complete screening assessments to check if they meet the study requirements.
- - Receive either ulinastatin for injection or placebo (inactive substance with no study drug) via intravenous drip.
- - Follow the study schedule for single sequential infusions and multiple continuous infusions.
- - Provide blood samples to measure drug concentration in the body.
- - Undergo safety evaluations including physical examinations, vital sign monitoring and laboratory tests throughout the study period.
- The study will compare data from participants receiving the study drug versus those receiving placebo to assess drug-related exposure and adverse reactions.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled Phase 1 study of ulinastatin for injection in healthy Chinese adults. Approximately 40 participants will be enrolled sequentially into 4 cohorts and randomized 8:2 to ulinastatin or placebo, to evaluate single ascending doses of 100,000 to 8,000,000 units and multiple ascending doses of 400,000 or 1,600,000 units administered three times daily for 4 consecutive days. Serial blood samples will be collected for non-compartmental pharmacokinetic analysis, and safety and tolerability will be assessed throughout the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- Participants are enrolled sequentially into 4 cohorts. Cohorts 1 and 2 are single-ascending-dose cohorts, in which each participant receives 3 sequential single doses on Days 1, 4, and 7. Cohorts 3 and 4 are multiple-ascending-dose cohorts, in which each participant receives three infusions daily for 4 consecutive days. Cohorts are enrolled in ascending dose order, with an interval of at least 2 weeks between cohorts; initiation of the next cohort is based on review of available safety data from the preceding cohort(s). Within each cohort, participants are randomized in an 8:2 ratio to ulinastatin or placebo
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Ulinastatin single ascending dose (100,000, 2,000,000, and 6,000,000 units) | Experimental | Drug: UlinastatinParticipants receive a single 2-hour intravenous infusion of ulinastatin 100,000 units on Day 1, 2,000,000 units on Day 4, and 6,000,000 units on Day 7. |
| Cohort 1: Placebo | Placebo comparator | Drug: PlaceboParticipants receive a single 2-hour intravenous infusion of placebo (5% glucose injection) on Days 1, 4, and 7, matching the ulinastatin schedule in Cohort 1. |
| Cohort 2: Ulinastatin single ascending dose (1,000,000, 4,000,000, and 8,000,000 units) | Experimental | Drug: UlinastatinParticipants receive a single 2-hour intravenous infusion of ulinastatin 1,000,000 units on Day 1, 4,000,000 units on Day 4, and 8,000,000 units on Day 7. |
| Cohort 2: Placebo | Placebo comparator | Drug: PlaceboParticipants receive a single 2-hour intravenous infusion of placebo (5% glucose injection) on Days 1, 4, and 7, matching the ulinastatin schedule in Cohort 2. |
| Cohort 3: Ulinastatin multiple ascending dose (400,000 units three times daily for 4 days) | Experimental | Drug: UlinastatinParticipants receive 2-hour intravenous infusions of ulinastatin 400,000 units three times daily (at 8:00, 16:00, and 23:00, ±1 hour) on Days 1 to 3, and one morning dose on Day 4 (last dose). |
| Cohort 3: Placebo | Placebo comparator | Drug: PlaceboParticipants receive infusions of placebo (5% glucose injection) three times daily on Days 1 to 3 and one morning dose on Day 4, matching the ulinastatin schedule in Cohort 3. |
| Cohort 4: Ulinastatin multiple ascending dose (1,600,000 units three times daily for 4 days) | Experimental | Drug: UlinastatinParticipants receive 2-hour intravenous infusions of ulinastatin 1,600,000 units three times daily (at 8:00, 16:00, and 23:00, ±1 hour) on Days 1 to 3, and one morning dose on Day 4 (last dose). |
| Cohort 4: Placebo | Placebo comparator | Drug: PlaceboParticipants receive infusions of placebo (5% glucose injection) three times daily on Days 1 to 3 and one morning dose on Day 4, matching the ulinastatin schedule in Cohort 4. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Chinese male or female participants, as confirmed by medical history, physical examination, vital signs, 12-lead ECG, chest X-ray, and laboratory tests at screening.
- Age 18 to 55 years, inclusive.
- Body mass index (BMI) 19.0 to 28.0 kg/m2, inclusive; body weight at least 45.0 kg for women and at least 50.0 kg for men.
- Able to understand the procedures and methods of the study, willing to comply strictly with the protocol, and able to provide written informed consent.
Key exclusion criteria (20 listed)
- Participants meeting any of the following criteria are not eligible for enrollment:
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 |
|---|---|---|
| UlinastatinName Ulinastatin for injection Type Drug Other Names Ulinastatin; UTI Lyophilized powder for injection, 100,000 units per vial; white to slightly yellow lyophilized cake or powder. Reconstituted and diluted in 250 mL of 5% glucose injection, then administered by intravenous infusion over 2 hours (±5 minutes). Single doses of 100,000 to 8,000,000 units were administered in the single-ascending-dose cohorts; doses of 400,000 or 1,600,000 units were administered three times daily for 4 consecutive days in the multiple-ascending-dose cohorts. Manufactured by Guangdong Techpool Biochemical Pharmaceutical Co., Ltd. | Drug | Cohort 1: Ulinastatin single ascending dose (100,000, 2,000,000, and 6,000,000 units), Cohort 2: Ulinastatin single ascending dose (1,000,000, 4,000,000, and 8,000,000 units), Cohort 3: Ulinastatin multiple ascending dose (400,000 units three times daily for 4 days), Cohort 4: Ulinastatin multiple ascending dose (1,600,000 units three times daily for 4 days) |
| PlaceboName Placebo Type Drug Other Names 5% glucose injection 250 mL of 5% glucose injection, prepared and administered so as to be indistinguishable in appearance from the reconstituted study drug. Contains no active ingredient. | Drug | Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo |
Primary outcome
Peak plasma concentration(Cmax)
Time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Area under the plasma concentration-time curve from time zero to the last quantifiable
Time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Time to reach peak plasma concentration (Tmax)
Time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Descriptive statistics by dose level; non-compartmental analysis.Blood samples were also collected at matching time points on Day -1 (baseline) for endogenous baseline correction.
Terminal elimination half-life (t1/2)
Time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Apparent clearance (CL)
Time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Apparent volume of distribution (Vz)
Time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7
Peak plasma concentration at steady state (Cmax,ss)
Time frame: Up to 24 hours after the start of the Day 4 infusion (last dose)
Trough plasma concentration at steady state (Cmin,ss)
Time frame: Predose on Day 4
Time to reach peak plasma concentration at steady state (Tmax,ss)
Time frame: Up to 24 hours after the start of the Day 4 infusion (last dose)
Area under the plasma concentration-time curve during a dosing interval at steady state (AUC0-tau,ss)
Time frame: Up to 24 hours after the start of the Day 4 infusion (last dose)
Accumulation ratio based on Cmax and AUC0-tau (Rac)
Time frame: Up to 24 hours after the start of the Day 4 infusion (last dose)
1 secondary outcome
Incidence and severity of adverse events (AEs)
Time frame: From the first dose up to 7 days (±1 day) after the 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 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The data are proprietary to the sponsor and are not made available to external parties.
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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.
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 Ulinastatin in people with Healthy Participants and Ulinastatin, run by Techpool Bio-Pharma 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 5 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: opening soon, as of the sponsor's last update on 6 Nov 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 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. 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?
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 Mingjuan Hua (+86-20-38972288, huamj@techpool.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration(Cmax) (time frame: Up to 24 hours after the start of each infusion on Days 1, 4, and 7). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.