Healthy ParticipantsPhase 1NCT07647783
A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2072 Tablets
A Phase 1 study testing SYH2072 Tablets in people with Healthy Participants, run by InnovStone Therapeutics Limited at 1 site in China.
Trial summary
This is a first-in-human study to evaluate the safety, tolerability, PK, and PD characteristics of SYH2072 Tablets after single and multiple oral doses in healthy participants. 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
- What is being tested?
- SYH2072 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 1 Apr 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 be fully informed about the study content, procedures, and potential adverse reactions, and voluntarily sign the written informed consent form (ICF) before the study;
- Sex: Male or female;
- Age: 18-55 years old (inclusive);
- Body mass index in the range of 19 to 30 kg•m-2 [Body Mass Index (BMI) = weight/height2 (kg•m^2)] (inclusive), with a body weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);
- Participants are able to communicate well with the investigator and are able to complete the study in accordance with the protocol.
Who cannot join
- History of severe allergic diseases or allergic constitution (allergy to ≥ 3 drugs or foods);
- Use of corticosteroid drugs within 3 months prior to screening;
- Past and/or current clinically significant medical conditions, including but not limited to diseases of the circulatory, hematologic or hematopoietic, respiratory, endocrine, urinary, digestive, nervous or psychiatric systems, infections, tumors, severe trauma, or any other disease that the investigator considers should be excluded or may interfere with the interpretation of the study results;
- Postural tachycardia (heart rate increase > 30 beats/minute upon standing) or postural hypotension (decrease in SBP ≥ 20mmHg or DBP ≥ 10mmHg upon standing) at screening;
- Have undergone major surgery within 6 months prior to screening, or plan to undergo major surgery during the study;
- Potassium ion level outside the normal range in clinical chemistry tests at screening, or serum creatinine > upper limit of normal (ULN);
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- Any one of the following at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) > 1.2×ULN (one re-test within 1 week is allowed);
- Estimated glomerular filtration rate (eGFR) < 90mL/min/1.73 m2 at screening;
- Prolonged QT/QTc interval at screening (QTcF ≥ 450ms for males, ≥ 470ms for females);
- Positive for any of the following: HBsAg, HCV antibody, syphilis antibody, or HIV antibody;
- Blood loss or blood donation exceeding 200mL within 3 months prior to screening (excluding menstruation for females), and/or platelet donation within 2 weeks;
- Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or dietary supplements (including vitamins, health products, etc.) within 28 days prior to screening;
- History of drug abuse, and/or use of illicit drugs within 3 months prior to screening, and/or habitual use of any psychotropic drugs, including Chinese herbal medicines, and/or a positive urine drug screen;
- Average daily smoking of more than 5 cigarettes (or an equivalent amount of tobacco in e-cigarettes) within 3 months prior to screening, and/or unwilling to avoid using any tobacco products during the study;
- Regular alcohol consumption within 6 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 360mL of 5% alcohol beer or 45mL of 40% alcohol spirits or 150mL of 12% alcohol wine), and/or inability to abstain from alcohol intake during the study, and/or a positive breath alcohol test;
- Excessive daily consumption of tea, coffee, and/or caffeinated beverages (8 cups or more, 1 cup = 250mL) within 1 month prior to screening, and/or unwilling to abstain from tea, coffee, and/or caffeinated foods, grapefruit and/or grapefruit juice, and/or poppy-containing products during the study;
- Having a fertility plan (including sperm or egg donation) from the time of signing the ICF until 3 months after the last dose, and/or unwilling to use an effective non-drug method of contraception;
- Participation in any clinical study within 3 months prior to screening;
- Participants who may be unable to complete the study for other reasons or who are deemed unsuitable for inclusion by the investigator.
- In addition to the above requirements, female participants who meet the following criteria will also be excluded:
- Pregnant or lactating women;
- Use of oral contraceptives within 28 days prior to screening;
- Use of long-acting estrogen and/or progestogen injections and/or implants within 6 months prior to screening; 23）Women of childbearing potential who have had unprotected sexual intercourse with a partner within 28 days prior to dosing.
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, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Yang Lin, +86-18910778667, linyang@anzhengcp.com
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2072 Tablets in Healthy Participants
This is a first-in-human study to evaluate the safety, tolerability, PK, and PD characteristics of SYH2072 Tablets after single and multiple oral doses in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- SYH2072 Tablets, SYH2072 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2072 TabletsDrug
SYH2072 tablets will be administered as a single or multiple oral doses.
SYH2072 PlaceboDrug
SYH2072 placebo tablets will be administered as a single or multiple oral doses.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses (SAD, Part A) | Experimental | In this part, 6 ascending dose cohorts (10 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 4:1 ratio to receive either SYH2072 or placebo. Receives: Drug: SYH2072 Tablets; Drug: SYH2072 Placebo |
| Food Effect (FE, Part B) | Experimental | 12 participants and single dose food effect cohort. Receives: Drug: SYH2072 Tablets |
| Experimental: Multiple Ascending Doses (MAD, Part C) | Experimental | In this part, 4 ascending dose cohorts (10 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 4:1 ratio to receive either SYH2072 or placebo. Receives: Drug: SYH2072 Tablets; Drug: SYH2072 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Adverse events
The rate of Adverse events occur during the whole study
Measured: Through study completion, an average of 8 months
The rate of normality or abnormality of electrocardiogram
The rate of normality or abnormality of electrocardiogram during the whole study
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Jan 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnovStone Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647783
- Sponsor's protocol ID
- SYH2072-001
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2072 Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT07647783
- Acronym / sponsor ID
- SYH2072-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- InnovStone Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 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.
This is a first-in-human study to evaluate the safety, tolerability, PK, and PD characteristics of SYH2072 Tablets after single and multiple oral doses in healthy participants.
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 Ascending Doses (SAD, Part A) | Experimental | Drug: SYH2072 Tablets, Drug: SYH2072 PlaceboIn this part, 6 ascending dose cohorts (10 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 4:1 ratio to receive either SYH2072 or placebo. |
| Food Effect (FE, Part B) | Experimental | Drug: SYH2072 Tablets12 participants and single dose food effect cohort. |
| Experimental: Multiple Ascending Doses (MAD, Part C) | Experimental | Drug: SYH2072 Tablets, Drug: SYH2072 PlaceboIn this part, 4 ascending dose cohorts (10 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 4:1 ratio to receive either SYH2072 or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be fully informed about the study content, procedures, and potential adverse reactions, and voluntarily sign the written informed consent form (ICF) before the study;
- Sex: Male or female;
- Age: 18-55 years old (inclusive);
- Body mass index in the range of 19 to 30 kg•m-2 [Body Mass Index (BMI) = weight/height2 (kg•m^2)] (inclusive), with a body weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive);
- Participants are able to communicate well with the investigator and are able to complete the study in accordance with the protocol.
Key exclusion criteria (23 listed)
- History of severe allergic diseases or allergic constitution (allergy to ≥ 3 drugs or foods);
- Use of corticosteroid drugs within 3 months prior to screening;
- Past and/or current clinically significant medical conditions, including but not limited to diseases of the circulatory, hematologic or hematopoietic, respiratory, endocrine, urinary, digestive, nervous or psychiatric systems, infections, tumors, severe trauma, or any other disease that the investigator considers should be excluded or may interfere with the interpretation of the study results;
- Postural tachycardia (heart rate increase > 30 beats/minute upon standing) or postural hypotension (decrease in SBP ≥ 20mmHg or DBP ≥ 10mmHg upon standing) at screening;
- Have undergone major surgery within 6 months prior to screening, or plan to undergo major surgery during the study;
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 |
|---|---|---|
| SYH2072 TabletsSYH2072 tablets will be administered as a single or multiple oral doses. | Drug | Experimental: Multiple Ascending Doses (MAD, Part C), Food Effect (FE, Part B), Single Ascending Doses (SAD, Part A) |
| SYH2072 PlaceboSYH2072 placebo tablets will be administered as a single or multiple oral doses. | Drug | Experimental: Multiple Ascending Doses (MAD, Part C), Single Ascending Doses (SAD, Part A) |
Primary outcome
The rate of Adverse events
Time frame: Through study completion, an average of 8 months
The rate of Adverse events occur during the whole study
The rate of normality or abnormality of electrocardiogram
Time frame: Through study completion, an average of 8 months
The rate of normality or abnormality of electrocardiogram during the whole study
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 15 Jun 2026.
- Individual participant dataSharing planned: No
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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 SYH2072 Tablets in people with Healthy Participants, run by InnovStone Therapeutics Limited 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 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 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. 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 Clinical Trials Information Group officer (+86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of Adverse events (time frame: Through study completion, an average of 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.