DyslipidemiaPhase 1NCT06669429
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy Subjects
A Phase 1 study testing RS-C1001 in people with Dyslipidemia, run by Peking University First Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of RS-C1001 tablets in Chinese healthy subjects. This study will consist of two parts (Parts A and B). 42 subjects have been planned for Part A and 30 subjects for Part B. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- RS-C1001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2024to 30 Aug 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects should fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily sign the informed consent.
- Healthy subjects aged 18-45 years old (including boundary values, subject to the time of signing the informed consent form), regardless of gender;
- Have a BMI between 19 and 26 kg/m2 (including the boundary value), and the weight of males is not less than 50 kg, and the weight of females is not less than 45 kg;
- Researchers determine that the overall health status of the subjects is good based on their medical history, physical examination, vital signs, 12 lead electrocardiogram , laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, early kidney damage detection), virus serology, and other results (normal or abnormal examination results have no clinical significance);
- The serum LDL-C of the enrolled subjects in MAD study is less than 4.1 mmol/L, and the serum TG is less than 3.4 mmol/L.
- Female participants must be in a negative pregnant and non lactating state; And female subjects of childbearing age and male subjects with female partners of childbearing age agree to use contraception from the screening period until 6 months after the last dose (using medically recognized effective contraceptive measures). Male subjects can only donate sperm 6 months after the last dose.
Who cannot join
- Individuals with a history of drug or other allergies, or those who may be allergic to the investigational drug or any component of the investigational drug as determined by the researcher;
- Subjects with abnormal clinical manifestations, including but not limited to neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, and skeletal system diseases, who have been evaluated by the researchers as unsuitable for participation in this study;
- Screening and baseline 12 lead electrocardiogram results (adjusted by Fridericia formula, QTcF=QT/(RR ^ 0.33), where RR=60/heart rate) for male subjects with QTcF (average of 3 consecutive test results) ≥ 450 ms and female subjects with QTcF ≥ 470 ms;
- Subjects with eGFR<80 mL/min/1.73m ²;
- Individuals who have a history of drug abuse within the past five years or have used drugs in the three months prior to screening, or who tested positive for drug abuse during screening or baseline;
- Individuals who have smoked more than 5 cigarettes per day or habitually used nicotine containing products within the previous 3 months, or who are unable to quit smoking during the trial period;
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- Individuals who have consumed more than 14 units of alcohol per week within the previous 3 months (1 unit of alcohol=360 mL of beer, 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or have taken alcoholic products within 48 hours prior to receiving the test drug, or have tested positive for alcohol breath test at baseline;
- Those who have suffered from clinically significant major diseases or undergone major surgical procedures within 28 days prior to receiving the investigational drug, or who are expected to undergo major surgery during the trial period;
- If the researcher determines that any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements have been used within 14 days before receiving the investigational drug, and the time interval between the start of the drug administration and the start of the trial is greater than 5 half lives, the corresponding subjects can also be enrolled; Within 30 days before accepting the investigational drug, use any known Chinese herbal medicine, vitamin, or tonic that can affect glucose and lipid metabolism (such as fish oil>1000 mg/day, drugs or health supplements containing Monascus rice ingredients);
- Those who consume any food or beverage containing or metabolized to produce caffeine or xanthine (such as coffee, tea, chocolate) within 48 hours prior to receiving the investigational drug;
- Screening period virus serological testing for subjects who are positive for human immunodeficiency virus antibodies (HIV Ab), HBV surface antigen (HBsAg), HCV antibodies (HCV Ab), or Treponema pallidum antibodies (TP Ab);
- Those who have difficulty in venous blood collection or have a history of needle and blood dizziness;
- Subjects with a history of grade 3 hypoglycemia;
- Subjects who have used other clinical trial drugs or participated in clinical trials of medical devices within the past 3 months prior to receiving the investigational drug;
- Subjects who have a history of blood donation or have lost more than 400 mL of blood in the three months prior to screening, or who plan to donate blood during the trial period;
- The researcher believes that the participant is not suitable to participate in the trial due to other reasons or withdraws from the trial due to personal reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Ran Xie
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of RS-C1001 Tablets in Chinese Healthy Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of RS-C1001 tablets in Chinese healthy subjects.
This study will consist of two parts (Parts A and B). 42 subjects have been planned for Part A and 30 subjects for Part B.
Read the detailed description
This is a Phase I, First In Human (FIH), randomized, double-blind, placebo-controlled study in Chinese healthy subjects.
42 subjects have been planned for Part A and 30 subjects for Part B.
Part A:
A Screening Period of maximum 14 days. Admission to study center (Day -1). A Treatment Period (Day 1 to Day 4) with a single dose of RS-C1001 or placebo on Day 1. Subjects will be discharged on Day 4.
A Follow-up Visit within 6 to 8 days after the Investigational Medicinal Product (IMP) dose for all cohorts.
(i) Part A1 - Up to 6 dose cohorts of RS-C1001 are planned to be investigated. Two subjects (one male and one female) planned to be enrolled in the 50 mg dose cohort will receive the investigational drug orally. The remaining 5 dose cohorts, 6 subjects will be randomized to receive RS-C1001, and 2 subjects randomized to receive placebo.
(ii) Part A2 - The subjects from a chosen cohort in Part A1 will return to the study center no sooner than 7 days after the first dose administration of IMP and will receive RS-C1001 or placebo after intake of a high-calorie, high-fat breakfast, to assess the effect of food on the PK of RS-C1001.
The subjects will stay at the study center until 72 hours post-dose in both the parts.
- Part B: Multiple Ascending Dose (MAD) cohort - Up to 3 dose cohorts are planned to be investigated. In each cohort, 10 subjects will participate and receive either RS-C1001 or placebo, randomized 4:1 for 10 days dosing.
Subjects will be discharged on Day 13. A Follow-up Visit within 15 to 17 days after the Investigational Medicinal Product (IMP) dose for all cohorts.
- Conditions
- Dyslipidemia
- Being tested
- RS-C1001, placebo
- Keywords
- RS-C1001 tablets Dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS-C1001Drug
Subjects will receive RS-C1001 tablets orally as a single ascending dose
RS-C1001Drug
Subjects will receive RS-C1001 tablets orally as a multiple ascending dose
RS-C1001Drug
Subjects will receive RS-C1001 tablets orally as a single dose after intake of a high-calorie, high-fat breakfast
placeboDrug
Subjects will receive placebo matching tne RS-C1001 dose orally as a single ascending dose
placeboDrug
Subjects will receive placebo matching tne RS-C1001 dose orally as a multiple ascending dose
PlaceboDrug
Subjects will receive placebo matching tne RS-C1001 dose orally as a single dose after intake of a high-calorie, high-fat breakfast
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Part A1-RS-C1001 tablet dose 1 | Experimental | Not described Receives: Drug: RS-C1001 |
| Cohort 2: Part A1-RS-C1001 tablet dose 2/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 3: Part A1-RS-C1001 tablet dose 3/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 4: Part A1-RS-C1001 tablet dose 4/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 5: Part A1-RS-C1001 tablet dose 5/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 6: Part A1-RS-C1001 tablet dose 6/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 7: Part A1-RS-C1001 tablet dose 6/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 8: Part A1-RS-C1001 tablet dose 8/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 9: Part A1-RS-C1001 tablet dose 9/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: placebo |
| Cohort 10: Part A1-RS-C1001 tablet dose 10/placebo tablet | Experimental | Not described Receives: Drug: RS-C1001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with Adverse Events (AEs) or Serious Adverse Events(SAEs).
Incidence, type, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 after single and multiple oral administration of RS-C1001 tablets in healthy male and female participants.
Measured: Part A1 (SAD): Day1-7; Part A2 (FE): Day1-14; Part B (MAD): Day1-16
Numbers of participants with clinical laboratory tests abnormalities
Safety blood and urine samples collected are assessed for lab values that move out of the normal range will be noted and assessed for clinical significance. Any clinically significant abnormality, including changes from baseline, must be reported as an AE.
Measured: Part A1 (SAD): Day2、Day4、Day7; Part A2 (FE): Day2、Day4、Day7、Day9、Day11、Day14; Part B (MAD): Day3、Day7、Day11、Day13、Day16
Numbers of participants with vital sign abnormalities
Numbers of participants with vital sign abnormalities
Measured: Part A1 (SAD): Day1-4、Day7; Part A2 (FE): Day1-4、Day7-11、Day14; Part B (MAD): Day1-13、Day16
Numbers of participants with physical examination abnormalities
Numbers of participants with physical examination abnormalities
Measured: Part A1 (SAD): Day2、Day4、Day7; Part A2 (FE): Day2、Day4、Day7、Day9、Day11、Day14; Part B (MAD): Day3、Day7、Day11、Day13、Day16
Number of participants with 12-lead electrocardiogram(ECG) abnormalities
Number of participants with 12-lead ECG abnormalities including PR, RR, QRS, QT and QTcF.
Measured: Part A1 (SAD): Day1-4、Day7; Part A2 (FE): Day1-4、Day7-11、Day14; Part B (MAD): Day1-13、Day16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start25 Sep 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669429
- Sponsor's protocol ID
- RS-C1001-C-1-1-001
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 1 Nov 2024
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of RS-C1001 Tablets in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06669429
- Acronym / sponsor ID
- RS-C1001-C-1-1-001
- Conditions
- Dyslipidemia
- Keywords
- RS-C1001 tablets Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 1 Nov 2024 (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 purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of RS-C1001 tablets in Chinese healthy subjects.
This study will consist of two parts (Parts A and B). 42 subjects have been planned for Part A and 30 subjects for Part B.
Detailed description
This is a Phase I, First In Human (FIH), randomized, double-blind, placebo-controlled study in Chinese healthy subjects.
42 subjects have been planned for Part A and 30 subjects for Part B.
Part A:
A Screening Period of maximum 14 days. Admission to study center (Day -1). A Treatment Period (Day 1 to Day 4) with a single dose of RS-C1001 or placebo on Day 1. Subjects will be discharged on Day 4.
A Follow-up Visit within 6 to 8 days after the Investigational Medicinal Product (IMP) dose for all cohorts.
(i) Part A1 - Up to 6 dose cohorts of RS-C1001 are planned to be investigated. Two subjects (one male and one female) planned to be enrolled in the 50 mg dose cohort will receive the investigational drug orally. The remaining 5 dose cohorts, 6 subjects will be randomized to receive RS-C1001, and 2 subjects randomized to receive placebo.
(ii) Part A2 - The subjects from a chosen cohort in Part A1 will return to the study center no sooner than 7 days after the first dose administration of IMP and will receive RS-C1001 or placebo after intake of a high-calorie, high-fat breakfast, to assess the effect of food on the PK of RS-C1001.
The subjects will stay at the study center until 72 hours post-dose in both the parts.
- Part B: Multiple Ascending Dose (MAD) cohort - Up to 3 dose cohorts are planned to be investigated. In each cohort, 10 subjects will participate and receive either RS-C1001 or placebo, randomized 4:1 for 10 days dosing.
Subjects will be discharged on Day 13. A Follow-up Visit within 15 to 17 days after the Investigational Medicinal Product (IMP) dose for all cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Part A1-RS-C1001 tablet dose 1 | Experimental | Drug: RS-C1001 |
| Cohort 2: Part A1-RS-C1001 tablet dose 2/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 3: Part A1-RS-C1001 tablet dose 3/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 4: Part A1-RS-C1001 tablet dose 4/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 5: Part A1-RS-C1001 tablet dose 5/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 6: Part A1-RS-C1001 tablet dose 6/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 7: Part A1-RS-C1001 tablet dose 6/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 8: Part A1-RS-C1001 tablet dose 8/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 9: Part A1-RS-C1001 tablet dose 9/placebo tablet | Experimental | Drug: RS-C1001, Drug: placebo |
| Cohort 10: Part A1-RS-C1001 tablet dose 10/placebo tablet | Experimental | Drug: RS-C1001, Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects should fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily sign the informed consent.
- Healthy subjects aged 18-45 years old (including boundary values, subject to the time of signing the informed consent form), regardless of gender;
- Have a BMI between 19 and 26 kg/m2 (including the boundary value), and the weight of males is not less than 50 kg, and the weight of females is not less than 45 kg;
- Researchers determine that the overall health status of the subjects is good based on their medical history, physical examination, vital signs, 12 lead electrocardiogram , laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, early kidney damage detection), virus serology, and other results (normal or abnormal examination results have no clinical significance);
- The serum LDL-C of the enrolled subjects in MAD study is less than 4.1 mmol/L, and the serum TG is less than 3.4 mmol/L.
Key exclusion criteria (16 listed)
- Individuals with a history of drug or other allergies, or those who may be allergic to the investigational drug or any component of the investigational drug as determined by the researcher;
- Subjects with abnormal clinical manifestations, including but not limited to neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, and skeletal system diseases, who have been evaluated by the researchers as unsuitable for participation in this study;
- Screening and baseline 12 lead electrocardiogram results (adjusted by Fridericia formula, QTcF=QT/(RR ^ 0.33), where RR=60/heart rate) for male subjects with QTcF (average of 3 consecutive test results) ≥ 450 ms and female subjects with QTcF ≥ 470 ms;
- Subjects with eGFR<80 mL/min/1.73m ²;
- Individuals who have a history of drug abuse within the past five years or have used drugs in the three months prior to screening, or who tested positive for drug abuse during screening or baseline;
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 |
|---|---|---|
| RS-C1001Subjects will receive RS-C1001 tablets orally as a single ascending dose | Drug | Cohort 1: Part A1-RS-C1001 tablet dose 1, Cohort 2: Part A1-RS-C1001 tablet dose 2/placebo tablet, Cohort 3: Part A1-RS-C1001 tablet dose 3/placebo tablet, Cohort 4: Part A1-RS-C1001 tablet dose 4/placebo tablet, Cohort 5: Part A1-RS-C1001 tablet dose 5/placebo tablet, Cohort 6: Part A1-RS-C1001 tablet dose 6/placebo tablet |
| RS-C1001Subjects will receive RS-C1001 tablets orally as a multiple ascending dose | Drug | Cohort 7: Part A1-RS-C1001 tablet dose 6/placebo tablet, Cohort 8: Part A1-RS-C1001 tablet dose 8/placebo tablet, Cohort 9: Part A1-RS-C1001 tablet dose 9/placebo tablet |
| RS-C1001Subjects will receive RS-C1001 tablets orally as a single dose after intake of a high-calorie, high-fat breakfast | Drug | Cohort 10: Part A1-RS-C1001 tablet dose 10/placebo tablet |
| placeboSubjects will receive placebo matching tne RS-C1001 dose orally as a single ascending dose | Drug | Cohort 2: Part A1-RS-C1001 tablet dose 2/placebo tablet, Cohort 3: Part A1-RS-C1001 tablet dose 3/placebo tablet, Cohort 4: Part A1-RS-C1001 tablet dose 4/placebo tablet, Cohort 5: Part A1-RS-C1001 tablet dose 5/placebo tablet, Cohort 6: Part A1-RS-C1001 tablet dose 6/placebo tablet |
| placeboSubjects will receive placebo matching tne RS-C1001 dose orally as a multiple ascending dose | Drug | Cohort 7: Part A1-RS-C1001 tablet dose 6/placebo tablet, Cohort 8: Part A1-RS-C1001 tablet dose 8/placebo tablet, Cohort 9: Part A1-RS-C1001 tablet dose 9/placebo tablet |
| PlaceboSubjects will receive placebo matching tne RS-C1001 dose orally as a single dose after intake of a high-calorie, high-fat breakfast | Drug | Cohort 10: Part A1-RS-C1001 tablet dose 10/placebo tablet |
Primary outcome
Numbers of participants with Adverse Events (AEs) or Serious Adverse Events(SAEs).
Time frame: Part A1 (SAD): Day1-7; Part A2 (FE): Day1-14; Part B (MAD): Day1-16
Incidence, type, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 after single and multiple oral administration of RS-C1001 tablets in healthy male and female participants.
Numbers of participants with clinical laboratory tests abnormalities
Time frame: Part A1 (SAD): Day2、Day4、Day7; Part A2 (FE): Day2、Day4、Day7、Day9、Day11、Day14; Part B (MAD): Day3、Day7、Day11、Day13、Day16
Safety blood and urine samples collected are assessed for lab values that move out of the normal range will be noted and assessed for clinical significance. Any clinically significant abnormality, including changes from baseline, must be reported as an AE.
Numbers of participants with vital sign abnormalities
Time frame: Part A1 (SAD): Day1-4、Day7; Part A2 (FE): Day1-4、Day7-11、Day14; Part B (MAD): Day1-13、Day16
Numbers of participants with vital sign abnormalities
Numbers of participants with physical examination abnormalities
Time frame: Part A1 (SAD): Day2、Day4、Day7; Part A2 (FE): Day2、Day4、Day7、Day9、Day11、Day14; Part B (MAD): Day3、Day7、Day11、Day13、Day16
Numbers of participants with physical examination abnormalities
Number of participants with 12-lead electrocardiogram(ECG) abnormalities
Time frame: Part A1 (SAD): Day1-4、Day7; Part A2 (FE): Day1-4、Day7-11、Day14; Part B (MAD): Day1-13、Day16
Number of participants with 12-lead ECG abnormalities including PR, RR, QRS, QT and QTcF.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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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.
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 RS-C1001 in people with Dyslipidemia, 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact professor (086-010-64009673, cuiymzy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants with Adverse Events (AEs) or Serious Adverse Events(SAEs). (time frame: Part A1 (SAD): Day1-7; Part A2 (FE): Day1-14; Part B (MAD): Day1-16). The study lists 5 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 Nov 2024.