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

NCT07647783 | Recruiting Phase 1

• 1 other identifier: SYH2072-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Drug: SYH2072 Tablets; Drug: SYH2072 Placebo

Food Effect (FE, Part B)

EXPERIMENTAL

12 participants and single dose food effect cohort.

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.

Drug: SYH2072 Tablets; Drug: SYH2072 Placebo

Interventions

SYH2072 Tablets DRUG

SYH2072 tablets will be administered as a single or multiple oral doses.

Experimental: Multiple Ascending Doses (MAD, Part C); Food Effect (FE, Part B); Single Ascending Doses (SAD, Part A)

SYH2072 Placebo DRUG

SYH2072 placebo tablets will be administered as a single or multiple oral doses.

Experimental: Multiple Ascending Doses (MAD, Part C); Single Ascending Doses (SAD, Part A)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• InnovStone Therapeutics Limited: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

+86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 15, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)