Evaluating SYH2062 Injection in Healthy Chinese Volunteers
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2062 Injection in Healthy Chinese Volunteers
This study is testing a new injection called SYH2062 in healthy Chinese volunteers to see if it's safe and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06842537 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SYH2062 injection in healthy Chinese volunteers. The study employs a randomized, double-blind, placebo-controlled design, where participants will receive either the SYH2062 injection or a matching placebo. The trial will involve a single administration of the injection to evaluate its effects and gather data on its safety profile. The study is crucial for understanding how this new drug behaves in the human body.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy Chinese volunteers aged 18 to 55 with a BMI between 19.0 and 26.0 kg/m².
Not a fit: Patients with known allergies to the study drug or similar drugs, or those with significant clinical diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of SYH2062, potentially leading to new treatment options.
How similar studies have performed: Other studies evaluating similar pharmacological interventions have shown promise, but this specific approach with SYH2062 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must give informed consent before the trial, fully understand the content, process and possible adverse reactions, and voluntarily sign a written informed consent. 2. Age of 18 - 55 years (inclusive). 3. BMI: 19.0-26.0 kg/m\^2 (inclusive), with a minimum weight of 50 kg (inclusive) for males and 45 kg (inclusive) for females. 4. Has Systolic blood pressure (SBP) ≥100 mmHg and \<140 mmHg and diastolic blood pressure (DBP) ≥60 mmHg and \<90 mmHg at screening; 5. The subjects can communicate well with the investigators and complete the trial according to protocol. Exclusion Criteria: Allergic constitution, or known history of allergy to the components of the study drug or similar drugs. 2 Subjects with the following diseases of clinical significance (including but not limited to diseases of the circulatory system, diseases of the blood or hematopoietic system, diseases of the respiratory system, diseases of the endocrine system, diseases of the urinary system, diseases of the digestive system, neurological or mental diseases, infections, tumors, serious injuries). 3 Those who underwent major surgery within 6 months prior to initial administration, or who planned to undergo surgery during the study. 4 Blood loss or blood donation of more than 200 mL within 3 months prior to initial administration (except for female menstrual period), and/or platelet donation within 2 weeks prior to initial administration. 5 Positive urine drug screening. 6 Those who smoked more than 5 cigarettes per day within 3 months prior to screening and/or did not agree to refrain from using any tobacco products during hospitalization. 7 Regular drinkers within 6 months prior to screening, i.e., those who drank more than 14 units of alcohol per week, and/or those who could not stop drinking alcohol during their hospitalization, and/or test positive for breath alcohol.
Where this trial is running
Beijing, Beijing Municipality
- Chinese Academy of Medical Science and Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wang Hongyun, Doctor
- Email: wanghy@pumch.cn
- Phone: +8618611513192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.