NCT07412353
Recruiting
Phase 1
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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country74 target enrollmentStarted: January 12, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- The Number of adverse events (AEs)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
SYH2085 SAD experimental group
Experimental
Participants in SAD experimental groups will receive a single oral administration of SYH2085 tablet on Day 1.
Intervention: SYH2085 (Drug)
Placebo SAD group
Placebo Comparator
Participants in SAD experimental groups will receive a single oral administration of placebo on Day 1.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The Number of adverse events (AEs)
Time Frame: Pre-dose and multiple timepoints no less than 22 days
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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