A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of
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 asce
| Condition(s) | Healthy Participants |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2026-01-12 |
| NCT ID | NCT07412353 |
| Official listing | https://clinicaltrials.gov/study/NCT07412353 |