Chinese Academy of Medical Science and Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Location status: Recruiting
NCT Number: NCT06842537
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of SYH2062 injection in healthy Chinese volunteers
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, China
Location status: Recruiting
A Phase 1, randomized, double-Blind, placebo-Controlled study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SYH2062 injection after a single administration in healthy subjects
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
SYH2062 for sc injection
Normal saline matching volume of SYH2062 doses will be administered
Time frame: up to approximately 12 months
Time frame: up to approximately 12 months
Time frame: up to approximately 12 months
Time frame: up to approximately 12 months
Time frame: up to approximately 12 months
Time frame: up to approximately 12 months
Time frame: up to approximately 12 months
Time frame: Up to Day 3
Time frame: Up to Day 3
Time frame: up to approximately 3 months
Contact information is provided by the study sponsor or research team.
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Industry
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2062 Injection in Healthy Chinese Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03971916
Healthy Chinese Volunteers
Hong Kong, China
View Trial DetailsNCT04495322
Healthy Chinese Volunteers
Changsha, Hunan, China
View Trial DetailsNCT03610867
Healthy Chinese Volunteers
Changsha, Hunan, China
View Trial DetailsNCT03610880
Healthy Chinese Volunteers
Changsha, Hunan, China
View Trial Details