A Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2072 Tablets

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: SYH2072 Tablets; Drug: SYH2072 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: +86-0311-69085587; Email: ctr-contact@cspc.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • Beijing AnZhen Hospital, Capital Medical University
      • Contact: Yang Lin; Phone Number: +86-18910778667; Email: linyang@anzhengcp.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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;
2. Sex: Male or female;
3. Age: 18-55 years old (inclusive);
4. 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);
5. Participants are able to communicate well with the investigator and are able to complete the study in accordance with the protocol.

Exclusion Criteria:

1. History of severe allergic diseases or allergic constitution (allergy to ≥ 3 drugs or foods);
2. Use of corticosteroid drugs within 3 months prior to screening;
3. 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;
4. Postural tachycardia (heart rate increase > 30 beats/minute upon standing) or postural hypotension (decrease in SBP ≥ 20mmHg or DBP ≥ 10mmHg upon standing) at screening;
5. Have undergone major surgery within 6 months prior to screening, or plan to undergo major surgery during the study;
6. Potassium ion level outside the normal range in clinical chemistry tests at screening, or serum creatinine > upper limit of normal (ULN);
7. 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);
8. Estimated glomerular filtration rate (eGFR) < 90mL/min/1.73 m2 at screening;
9. Prolonged QT/QTc interval at screening (QTcF ≥ 450ms for males, ≥ 470ms for females);
10. Positive for any of the following: HBsAg, HCV antibody, syphilis antibody, or HIV antibody;
11. Blood loss or blood donation exceeding 200mL within 3 months prior to screening (excluding menstruation for females), and/or platelet donation within 2 weeks;
12. 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;
13. 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;
14. 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;
15. 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;
16. 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;
17. 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;
18. Participation in any clinical study within 3 months prior to screening;

19. 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:

20. Pregnant or lactating women;
21. Use of oral contraceptives within 28 days prior to screening;
22. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Doses (SAD, Part A); 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.	Drug: SYH2072 Tablets; SYH2072 tablets will be administered as a single or multiple oral doses.; Drug: SYH2072 Placebo; SYH2072 placebo tablets will be administered as a single or multiple oral doses.
Experimental: Food Effect (FE, Part B); 12 participants and single dose food effect cohort.	Drug: SYH2072 Tablets; SYH2072 tablets will be administered as a single or multiple oral doses.
Experimental: Experimental: Multiple Ascending Doses (MAD, Part C); 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.	Drug: SYH2072 Tablets; SYH2072 tablets will be administered as a single or multiple oral doses.; Drug: SYH2072 Placebo; SYH2072 placebo tablets will be administered as a single or multiple oral doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of Adverse events	The rate of Adverse events occur during the whole study	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	Through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: InnovStone Therapeutics Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SYH2072-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No