A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085

A Phase І, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYH2085 in Chinese Healthy Participants

Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2085 tablet. Part 2 is to assess the food effect on SYH2085 at a selected dose in a cross-over design.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Trials Information Group officer
  • Phone Number: 031169085587
  • Email: ctr-contact@cspc.cn

Study Contact Backup

Study Locations

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age of 18 - 45 years (inclusive), male or female; BMI: 19.0-28.0 kg/m^2 (inclusive), with a minimum weight of 50.0 kg (inclusive) for male and 45.0 kg (inclusive) for female;
  2. Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray);
  3. Participants and their partners agree to use effective and reliable contraceptive methods to avoid pregnancy, and male subjects had no plans to donate sperm, and female subjects had no plans to donate eggs, from the time they signed the informed consent to 3 months after the end of the study;
  4. Participants must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.

Exclusion Criteria:

  1. History of hypersensitivity or allergy to drug or food, or any component of the study drug;
  2. Participants with a history of serious diseases, including pancreas, cardiovascular, liver, kidney, blood and lymphatic, central nervous system, and gastrointestinal systems, or other important diseases that may affect the absorption, metabolism, or excretion of the study drug;
  3. History of gastrointestinal surgery or resection that may alter the absorption and/or elimination of orally administered drugs (except for appendectomy);
  4. Participants who have undergone any surgical procedure within 6 months prior to the trial;
  5. Participants with a history of respiratory or systemic acute infection within 2 weeks prior to screening;
  6. Participants who have experienced blood loss exceeding 400 mL (e.g., due to blood donation or other reasons) within 3 months prior to the trial;
  7. Participants who have participated in another investigational drug study within 3 months prior to the planned administration of the study drug, where the last dose was received less than 3 months before screening for this trial; or subjects who plan to participate in another drug trial during the course of this study;
  8. Participants who have been vaccinated within 28 days prior to screening or plan to receive vaccination during the trial period;
  9. Participants who have taken any prescription drugs, over-the-counter (OTC) medications, Chinese patent medicines, herbal medicines, health supplements, or oral supplements (e.g., calcium, iron, magnesium, selenium, zinc, etc.) within 28 days prior to screening or during the trial period;
  10. Participants who have used oral long-acting contraceptives or implanted long-acting contraceptives within 28 days prior to screening;
  11. Participants who have used any known inducers or inhibitors of hepatic enzymes (e.g., grapefruit, orange juice, etc.) within 28 days prior to screening or during the trial period;
  12. Participants with any electrocardiogram (ECG) abnormality considered clinically significant by the investigator, including but not limited to: QTcF interval ≥450 ms, or a history of QTcF interval prolongation; PR interval ≥210 ms; QRS duration ≥120 ms; or a history of arrhythmia, syncope related to arrhythmia, use of a cardiac pacemaker, or other cardiac-related conditions. Note: Conditions include but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, premature atrial contractions, premature ventricular contractions, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of Long QT Syndrome (LQTS); or family history of sudden death;
  13. Participants with one or more abnormal vital signs at screening: aural temperature >37.5°C, pulse rate >100 beats per minute, systolic blood pressure ≥140 mmHg or <90 mmHg, diastolic blood pressure ≥90 mmHg or <50 mmHg;
  14. Participants who smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or who are unable to discontinue the use of any tobacco products during the trial period;
  15. Participants who habitually consumed excessive amounts of xanthine- or caffeine-containing foods, beverages, or other items that may affect drug absorption, distribution, metabolism, or excretion within 1 month prior to screening and are unwilling to abstain during the trial. Examples include: coffee (>1100 mL daily), tea (>2200 mL daily), cola (>2200 mL daily), energy drinks (>1100 mL daily), chocolate (>510 g daily);
  16. Participants with alcohol abuse: alcohol consumption exceeding 14 units per week within 1 month prior to signing the informed consent form (1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine);
  17. Participants with a positive alcohol breath test (>0 mg/100 mL) or those unable to abstain from alcohol during the trial period;
  18. Participants with a positive result for any of the following: Hepatitis B virus surface antigen (HBsAg), anti-Hepatitis C virus antibody (Anti-HCV), Treponema pallidum specific antibody, or anti-Human Immunodeficiency Virus antibody (Anti-HIV);
  19. Participants with a history of drug abuse and/or use of illicit drugs within 3 months prior to screening;
  20. Participants with a positive urine drug screen;
  21. Participants with a history of needle phobia, blood phobia, or intolerance to venipuncture for blood sampling;
  22. Participants who are pregnant, breastfeeding, or have a positive β-HCG pregnancy test;
  23. Participants with specific dietary requirements who cannot comply with the standardized diet and schedule;
  24. Participants deemed unsuitable for participation in this study by the investigator for any other reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYH2085 SAD experimental group
Participants in SAD experimental groups will receive a single oral administration of SYH2085 tablet on Day 1.
oral administration
Placebo Comparator: Placebo SAD group
Participants in SAD experimental groups will receive a single oral administration of placebo on Day 1.
oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Number of adverse events (AEs)
Time Frame: Pre-dose and multiple timepoints no less than 22 days
Pre-dose and multiple timepoints no less than 22 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve (AUC)
Time Frame: Pre-dose and multiple timepoints no less than 22 days
Pre-dose and multiple timepoints no less than 22 days
Plasma Maximum concentration (Cmax)
Time Frame: Pre-dose and multiple timepoints no less than 22 days
Pre-dose and multiple timepoints no less than 22 days
Half-Life (t1/2)
Time Frame: Pre-dose and multiple timepoints no less than 22 days
Pre-dose and multiple timepoints no less than 22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

November 12, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SYH2085-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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