ThrombosisPhase 1NCT07618351
A Phase I SAD/MAD and Liver Effect Study of Vitalangio in Venous Thromboembolism Patients .
A Phase 1 study testing Experimental: Food effect group and Active Comparator: Multiple dose group in people with Thrombosis and Cardiovascular Diseases, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug, Vitalangio1, in healthy male and female volunteers aged 18 to 55 years old. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis, Cardiovascular Diseases
- What is being tested?
- Experimental: Food effect group and Active Comparator: Multiple dose group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 627 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to 12 Mar 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18-55 years (including boundary values)
- Body mass index (BMI) 19-26 kg/m2 (including boundary value), male body weight >= 50.0 kg and <90.0 kg, female body weight >= 45.0 kg and <90.0 kg
- In good health with no clinically significant abnormalities as determined by physical examination, clinical laboratory tests ,12-lead ECG ,abdominal B-ultrasound and chest X-ray examination
- Subjects with Fertility (including partners) are willing to voluntarily take effective measures for reasonable contraception within 6 months from the beginning of screening to the last administration of trial drugs; Postmenopausal women should have a menopausal period of >= 1 year ; Within 6 months after receiving the investigational drug, male subjects agreed to use acceptable contraceptive measures and promised not to donate sperm; Female participants agree to use acceptable contraceptive measures and ensure that they do not donate eggs within 6 months from the start of screening until receiving the investigational medication
- Understand the research procedures and methods, willing and able to give written informed consent and comply with the study procedures and restrictions
Who cannot join
- Vital sign examination: body temperature>37.3 ℃, pulse>100 beats/minute, systolic blood pressure >= 140 mmHg or<90 mmHg, diastolic blood pressure >= 90 mmHg or<50 mmHg; The screening period electrocardiogram examination results showed that QTcF>450 ms (male) or 470 ms (female) or conduction block, which was determined by the researcher to be clinically significant
- Those who have one or more positive testing at screening for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody
- Those who have a history of drug abuse ; have a positive urine drug screen result for drugs of abuse at the screening visit
- Alanine transaminase, AST, creatinine>ULN; Alkaline phosphatase, bilirubin (total bilirubin or direct bilirubin)>1.5 × ULN
- Those who are suspected of being allergic to the study drug or any ingredient in the study drug
- Those who have a history of related diseases that lead to abnormal coagulation function in the past
Show all 13Show fewer
- Those who have a history of recurrent or chronic infection within one month prior to screening
- Those who have undergone surgeries within the first 6 months of screening that have been determined by researchers to affect drug absorption, distribution, metabolism, and excretion
- Those who consume foods within the first 2 weeks of screening that may affect the metabolism of drugs in the body, or those who are considered by researchers to have other diets that affect drug absorption, distribution, metabolism, and excretion
- Those who have taken any prescription drugs, Over-the-counter drug, health products and Chinese herbal medicines within 2 weeks before screening, or who have taken within 5 half lives of drugs during screening; Plan to take other investigational drugs not included in this study during the trial period
- Within one month before screening,any dosage form of vaccine needs to be used
- Those who donate blood or have a total blood loss of >= 200 mL from 1 month prior to screening to administration, or who donate blood or have a total blood loss of >= 400 mL from 3 months prior to screening to administration, or who have received blood transfusions from 8 weeks prior to screening to administration
- The investigators believe that the subjects are not suitable for other situations in this experime
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single, and Multiple-dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Vitalangio1 in Venous Thromboembolism Patients and a Randomized, Open-label, 2-period Crossover Liver Effect Study
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug, Vitalangio1, in healthy male and female volunteers aged 18 to 55 years old.
The main questions it aims to answer are:
Read more
What is the safety and tolerability profile of Vitalangio1 following single and multiple-dose administrations? What are the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Vitalangio1, and how does food intake affect its absorption and drug metabolism? Researchers will compare participants receiving Vitalangio1 tablets with those receiving a placebo to see if the drug is safe, well-tolerated, and demonstrates the expected pharmacological effects compared to no active treatment.
Participants will:
Receive either Vitalangio1 tablets or a placebo orally (through single or multiple escalating doses).
Participate in a 2-period crossover food effect study, taking the study drug under different dietary conditions (fasted vs. fed).
Undergo continuous medical monitoring, including physical examinations, vital sign measurements, ECGs, and provide blood/urine samples to track the drug's metabolic and safety profile.
- Conditions
- Thrombosis, Cardiovascular Diseases
- Being tested
- Placebo Comparator: Single dose group, Experimental: Food effect group, Active Comparator: Multiple dose group
- Medical subject headings
- Thrombosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Comparator: Single dose groupDrug
In this randomized, double-blind, placebo-controlled arm, eligible healthy participants will be assigned to different consecutive dose-escalation cohorts. Within each cohort, participants will be randomized to receive either a single oral dose of Vitalangio1 tablets or visually identical placebo tablets. The administration will take place under strict fasting conditions (typically following an overnight fast of at least 10 hours) with a standard volume of water. The study follows a sequential dose-escalation design: the first cohort will receive the lowest predefined starting dose. Subsequent cohorts will only receive the next higher dose level after an independent Safety Review Committee (SRC) thoroughly evaluates the safety, tolerability, and preliminary pharmacokinetic (PK) data from the preceding cohort and confirms it is safe to proceed. The primary focus is to monitor for any acute adverse events and determine the maximum tolerated single dose.
Experimental: Food effect groupDrug
This open-label, randomized, two-sequence, two-perio Vitalangio1. Participants will be randomized to receive a single, fixed oral dose of td crossover arm evaluates how food impacts the absorption and pharmacokinetics of he drug under two alternating conditions: strictly fasted (following an overnight fast) or fed (30 minutes after a standardized high-fat, high-calorie breakfast).
Following the Period 1 administration, a 7-day washout period will be implemented to ensure complete drug elimination. In Period 2, participants will cross over to receive the exact same dose under the alternate dietary condition. No placebo is utilized in this arm. During both periods, intensive blood sampling will be conducted to evaluate and compare key pharmacokinetic parameters, specifically the maximum plasma concentration (Cmax) and area under the curve (AUC), between the fasted and fed states.
Active Comparator: Multiple dose groupDrug
This arm also employs a randomized, double-blind, placebo-controlled, sequential dose-escalation design, but focuses on the cumulative effects of the drug. Healthy participants within each dose cohort will be randomized to receive repeated oral administrations of either Vitalangio1 tablets or a matching placebo. The intervention involves taking the study drug continuously over a predetermined number of consecutive days at a specific frequency (e.g., once or twice daily, as guided by the pharmacokinetic results from the single-dose arm). Administration will typically occur at the same time each day to maintain steady-state drug levels. Similar to the single-dose arm, dose escalation to the next cohort is strictly contingent upon a comprehensive safety and tolerability review of the current cohort's data. This arm is designed to assess steady-state pharmacokinetics, drug accumulation, and sustained safety profiles over a prolonged dosing period.
| Study group | Role | What they receive |
|---|---|---|
| Single dose group | Placebo comparator | Participants will receive either Vitalangio1 oral tablets or a matching placebo. The intervention consists of a single oral administration at escalating dose levels, which are determined by the safety and tolerability dose-escalation protocol, meaning the actual treatment duration for this specific intervention is only one day. Receives: Drug: Placebo Comparator: Single dose group |
| Food effect group | Experimental | Participants follows a two-period crossover design where participants will exclusively receive a selected fixed single dose of the Vitalangio1 oral tablet. The intervention requires each participant to take the single oral dose under two distinct dietary conditions-once in a completely fasted state and once following a high-fat meal. These two administration periods are separated by a specific washout duration, typically seven days, to accurately assess the impact of food on drug absorption. Receives: Drug: Experimental: Food effect group |
| Multiple dose group | Active comparator | The intervention involves the administration of Vitalangio1 oral tablets or a placebo over a continuous timeframe. Participants will receive multiple escalating doses on consecutive days, with the precise dosage, daily frequency, and overall duration dictated by the multiple-dose testing protocol to evaluate cumulative safety and pharmacokinetics. Receives: Drug: Active Comparator: Multiple dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety and tolerability will be evaluated by monitoring the incidence, severity, and causality of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). The assessment also includes monitoring clinically significant changes from baseline in vital signs (such as blood pressure, heart rate, and temperature), 12-lead electrocardiograms (ECGs), physical examinations, and clinical laboratory parameters (hematology, serum chemistry, and urinalysis) across the single-dose, multiple-dose, and food effect groups.
Measured: From the time of the first dose of the study drug until the end of the final safety follow-up visit (typically up to 7 to 14 days following the last dose administration).
Pharmacokinetics (PK): Maximum Observed Plasma Concentration
The maximum observed plasma concentration of the active components (e.g., serine protease/nattokinase and relevant metabolites) will be determined from the plasma concentration-time profile.
Measured: Pre-dose and at multiple time points post-dose up to 72 hours (e.g., 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours).
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Safety assessment includes monitoring the number of participants with clinically significant abnormalities compared to baseline in hematology, serum chemistry, and urinalysis (including liver and kidney function tests).
Measured: From baseline (Day 0) to Day 14 post-administration.
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve
The area under the plasma concentration-time curve from time zero to the last measurable concentration will be calculated to assess the total systemic exposure of the intervention.
Measured: Pre-dose and at multiple time points post-dose up to 72 hours.
Secondary outcomes (3)
Change from Baseline in Coagulation Function: Coagulation Factor XI (FXI) Activity
Pharmacodynamic efficacy will be assessed by measuring the percentage change in plasma Coagulation Factor XI (FXI) activity levels from baseline, evaluating the intervention's impact on the intrinsic coagulation pathway.
Measured: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
Change from Baseline in Standard Coagulation Parameters
The effect of the intervention on overall coagulation status will be evaluated by measuring the absolute change in activated partial thromboplastin time (aPTT) and prothrombin time (PT) in seconds.
Measured: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
Change from Baseline in Platelet Reactivity
Platelet function and hyperreactivity will be evaluated by measuring the change from baseline in platelet aggregation, specifically monitoring pathways potentially modulated by the intervention (e.g., high-throughput assessment of receptor-mediated platelet activation, including PEAR1-related pathways). Results will be reported as the percentage of maximal platelet aggregation.
Measured: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 24, and 48 hours post-dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start20 Jun 2023
- Primary completion23 Jan 2025
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618351
- Sponsor's protocol ID
- PKUFH-VTE-MASLD-2026
- Status last verified
- Apr 2026
- First submitted
- 17 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single, and Multiple-dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Vitalangio1 in Venous Thromboembolism Patients and a Randomized, Open-label, 2-period Crossover Liver Effect Study
- ClinicalTrials.gov ID
- NCT07618351
- Acronym / sponsor ID
- PKUFH-VTE-MASLD-2026
- Conditions
- Thrombosis, Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 1 Jun 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.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug, Vitalangio1, in healthy male and female volunteers aged 18 to 55 years old.
The main questions it aims to answer are:
What is the safety and tolerability profile of Vitalangio1 following single and multiple-dose administrations? What are the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Vitalangio1, and how does food intake affect its absorption and drug metabolism? Researchers will compare participants receiving Vitalangio1 tablets with those receiving a placebo to see if the drug is safe, well-tolerated, and demonstrates the expected pharmacological effects compared to no active treatment.
Participants will:
Receive either Vitalangio1 tablets or a placebo orally (through single or multiple escalating doses).
Participate in a 2-period crossover food effect study, taking the study drug under different dietary conditions (fasted vs. fed).
Undergo continuous medical monitoring, including physical examinations, vital sign measurements, ECGs, and provide blood/urine samples to track the drug's metabolic and safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose group | Placebo comparator | Drug: Placebo Comparator: Single dose groupParticipants will receive either Vitalangio1 oral tablets or a matching placebo. The intervention consists of a single oral administration at escalating dose levels, which are determined by the safety and tolerability dose-escalation protocol, meaning the actual treatment duration for this specific intervention is only one day. |
| Food effect group | Experimental | Drug: Experimental: Food effect groupParticipants follows a two-period crossover design where participants will exclusively receive a selected fixed single dose of the Vitalangio1 oral tablet. The intervention requires each participant to take the single oral dose under two distinct dietary conditions-once in a completely fasted state and once following a high-fat meal. These two administration periods are separated by a specific washout duration, typically seven days, to accurately assess the impact of food on drug absorption. |
| Multiple dose group | Active comparator | Drug: Active Comparator: Multiple dose groupThe intervention involves the administration of Vitalangio1 oral tablets or a placebo over a continuous timeframe. Participants will receive multiple escalating doses on consecutive days, with the precise dosage, daily frequency, and overall duration dictated by the multiple-dose testing protocol to evaluate cumulative safety and pharmacokinetics. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects aged 18-55 years (including boundary values)
- Body mass index (BMI) 19-26 kg/m2 (including boundary value), male body weight >= 50.0 kg and <90.0 kg, female body weight >= 45.0 kg and <90.0 kg
- In good health with no clinically significant abnormalities as determined by physical examination, clinical laboratory tests ,12-lead ECG ,abdominal B-ultrasound and chest X-ray examination
- Subjects with Fertility (including partners) are willing to voluntarily take effective measures for reasonable contraception within 6 months from the beginning of screening to the last administration of trial drugs; Postmenopausal women should have a menopausal period of >= 1 year ; Within 6 months after receiving the investigational drug, male subjects agreed to use acceptable contraceptive measures and promised not to donate sperm; Female participants agree to use acceptable contraceptive measures and ensure that they do not donate eggs within 6 months from the start of screening until receiving the investigational medication
- Understand the research procedures and methods, willing and able to give written informed consent and comply with the study procedures and restrictions
Key exclusion criteria (13 listed)
- Vital sign examination: body temperature>37.3 ℃, pulse>100 beats/minute, systolic blood pressure >= 140 mmHg or<90 mmHg, diastolic blood pressure >= 90 mmHg or<50 mmHg; The screening period electrocardiogram examination results showed that QTcF>450 ms (male) or 470 ms (female) or conduction block, which was determined by the researcher to be clinically significant
- Those who have one or more positive testing at screening for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody
- Those who have a history of drug abuse ; have a positive urine drug screen result for drugs of abuse at the screening visit
- Alanine transaminase, AST, creatinine>ULN; Alkaline phosphatase, bilirubin (total bilirubin or direct bilirubin)>1.5 × ULN
- Those who are suspected of being allergic to the study drug or any ingredient in the study drug
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 |
|---|---|---|
| Placebo Comparator: Single dose groupIn this randomized, double-blind, placebo-controlled arm, eligible healthy participants will be assigned to different consecutive dose-escalation cohorts. Within each cohort, participants will be randomized to receive either a single oral dose of Vitalangio1 tablets or visually identical placebo tablets. The administration will take place under strict fasting conditions (typically following an overnight fast of at least 10 hours) with a standard volume of water. The study follows a sequential dose-escalation design: the first cohort will receive the lowest predefined starting dose. Subsequent cohorts will only receive the next higher dose level after an independent Safety Review Committee (SRC) thoroughly evaluates the safety, tolerability, and preliminary pharmacokinetic (PK) data from the preceding cohort and confirms it is safe to proceed. The primary focus is to monitor for any acute adverse events and determine the maximum tolerated single dose. | Drug | Single dose group |
| Experimental: Food effect groupThis open-label, randomized, two-sequence, two-perio Vitalangio1. Participants will be randomized to receive a single, fixed oral dose of td crossover arm evaluates how food impacts the absorption and pharmacokinetics of he drug under two alternating conditions: strictly fasted (following an overnight fast) or fed (30 minutes after a standardized high-fat, high-calorie breakfast). Following the Period 1 administration, a 7-day washout period will be implemented to ensure complete drug elimination. In Period 2, participants will cross over to receive the exact same dose under the alternate dietary condition. No placebo is utilized in this arm. During both periods, intensive blood sampling will be conducted to evaluate and compare key pharmacokinetic parameters, specifically the maximum plasma concentration (Cmax) and area under the curve (AUC), between the fasted and fed states. | Drug | Food effect group |
| Active Comparator: Multiple dose groupThis arm also employs a randomized, double-blind, placebo-controlled, sequential dose-escalation design, but focuses on the cumulative effects of the drug. Healthy participants within each dose cohort will be randomized to receive repeated oral administrations of either Vitalangio1 tablets or a matching placebo. The intervention involves taking the study drug continuously over a predetermined number of consecutive days at a specific frequency (e.g., once or twice daily, as guided by the pharmacokinetic results from the single-dose arm). Administration will typically occur at the same time each day to maintain steady-state drug levels. Similar to the single-dose arm, dose escalation to the next cohort is strictly contingent upon a comprehensive safety and tolerability review of the current cohort's data. This arm is designed to assess steady-state pharmacokinetics, drug accumulation, and sustained safety profiles over a prolonged dosing period. | Drug | Multiple dose group |
Primary outcome
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the time of the first dose of the study drug until the end of the final safety follow-up visit (typically up to 7 to 14 days following the last dose administration).
Safety and tolerability will be evaluated by monitoring the incidence, severity, and causality of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). The assessment also includes monitoring clinically significant changes from baseline in vital signs (such as blood pressure, heart rate, and temperature), 12-lead electrocardiograms (ECGs), physical examinations, and clinical laboratory parameters (hematology, serum chemistry, and urinalysis) across the single-dose, multiple-dose, and food effect groups.
Pharmacokinetics (PK): Maximum Observed Plasma Concentration
Time frame: Pre-dose and at multiple time points post-dose up to 72 hours (e.g., 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours).
The maximum observed plasma concentration of the active components (e.g., serine protease/nattokinase and relevant metabolites) will be determined from the plasma concentration-time profile.
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: From baseline (Day 0) to Day 14 post-administration.
Safety assessment includes monitoring the number of participants with clinically significant abnormalities compared to baseline in hematology, serum chemistry, and urinalysis (including liver and kidney function tests).
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve
Time frame: Pre-dose and at multiple time points post-dose up to 72 hours.
The area under the plasma concentration-time curve from time zero to the last measurable concentration will be calculated to assess the total systemic exposure of the intervention.
3 secondary outcomes
Change from Baseline in Coagulation Function: Coagulation Factor XI (FXI) Activity
Time frame: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
Change from Baseline in Standard Coagulation Parameters
Time frame: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 8, 24, and 48 hours post-dose).
Change from Baseline in Platelet Reactivity
Time frame: Pre-dose (baseline) and at prespecified time points (e.g., 2, 4, 24, and 48 hours post-dose).
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 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 Experimental: Food effect group and Active Comparator: Multiple dose group in people with Thrombosis and Cardiovascular Diseases, run by Peking University First Hospital 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 13 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 1 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the time of the first dose of the study drug until the end of the final safety follow-up visit (typically up to 7 to 14 days following the last dose administration).). 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 1 Jun 2026.