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RECRUITINGPHASE1

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

NCT07412353•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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;
+14 more criteria

Locations (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 12, 2026

Primary Completion Date

November 12, 2026

Completion Date

December 31, 2026

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Participants

Interventions

SYH2085

DRUG

Placebo

DRUG

Contacts

Clinical Trials Information Group officer

CONTACT

031169085587 ctr-contact@cspc.cn

Xiaojie Wu

CONTACT

86-13524686330 maomao_xj@163.com

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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