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

NCT07412353 | Recruiting Phase 1

• 1 other identifier: SYH2085-001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• The Number of adverse events (AEs)

  Pre-dose and multiple timepoints no less than 22 days

Secondary Outcomes (3)

• Area under the concentration-time curve (AUC)

  Pre-dose and multiple timepoints no less than 22 days

• Plasma Maximum concentration (Cmax)

  Pre-dose and multiple timepoints no less than 22 days

• Half-Life (t1/2)

  Pre-dose and multiple timepoints no less than 22 days

Study Arms (2)

SYH2085 SAD experimental group

EXPERIMENTAL

Participants in SAD experimental groups will receive a single oral administration of SYH2085 tablet on Day 1.

Drug: SYH2085

Placebo SAD group

PLACEBO COMPARATOR

Participants in SAD experimental groups will receive a single oral administration of placebo on Day 1.

Drug: Placebo

Interventions

SYH2085 DRUG

oral administration

SYH2085 SAD experimental group

Placebo DRUG

oral administration

Placebo SAD group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray);
• 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;
• Participants must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.

You may not qualify if:

• History of hypersensitivity or allergy to drug or food, or any component of the study drug；
• 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;
• History of gastrointestinal surgery or resection that may alter the absorption and/or elimination of orally administered drugs (except for appendectomy);
• Participants who have undergone any surgical procedure within 6 months prior to the trial;
• Participants with a history of respiratory or systemic acute infection within 2 weeks prior to screening;
• 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;
• 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;
• Participants who have been vaccinated within 28 days prior to screening or plan to receive vaccination during the trial period;
• 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;
• Participants who have used oral long-acting contraceptives or implanted long-acting contraceptives within 28 days prior to screening;
• 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;
• 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;
• 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;
• 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；
• 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);

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Xiaojie Wu

CONTACT

86-13524686330; maomao_xj@163.com

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

Model Details: Drug: SYH2085 Other: Placebo

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

CN (1)