A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of STSP-0902 in Healthy Subjects
- Conditions
- AsthenozoospermiaOligozoospermia
- Registration Number
- NCT06563713
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria:<br><br> 1. Healthy male volunteers, aged between 18 and 50 years inclusive, with a body weight<br> of at least 50.0 kg, and a body mass index (BMI) between 19.0 and 28.0 kg/m²<br> inclusive, and whose routine semen analysis results during the screening period meet<br> the criteria of a total sperm count of less than 180 million (or a sperm<br> concentration of less than 63 million) or a percentage of progressively motility<br> sperm of less than 56%.<br><br> 2. Participants (including the partners of the participants) must use effective<br> non-drug contraceptive measures during the trial period and for four months after<br> the end of administration, and must not have plans for pregnancy or sperm donation.<br><br> 3. Subjects must give informed consent to this study before the study and voluntarily<br> sign a written informed consent form.<br><br>Exclusion Criteria:<br><br> 1. Participants with a history of severe diseases, including but not limited to<br> conditions affecting the skeletal, neuropsychiatric, cardiovascular, hematologic,<br> hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immune, and<br> reproductive systems (such as reproductive system infectious diseases, varicocele,<br> reproductive tract obstruction, etc., except for oligoasthenzoospermia), as judged<br> by the investigator, may endanger the safety of the participant or affect the study<br> results.<br><br> 2. Participants who have planned to receive treatments related to<br> oligoasthenzoospermia, such as zinc sulfate, levocarnitine, escin, or pancreatic<br> kallikrein, within 3 months prior to screening or during the trial period.<br><br> 3. Participants with a history of treatment with nerve growth factor-like drug therapy<br> (such as mouse nerve growth factor for injection) within 3 months prior to<br> screening.<br><br> 4. Subjects who have undergone any major surgery within 3 months prior to screening or<br> have surgery planned during the trial period.<br><br> 5. Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory<br> tests, and results of all tests related to the trial (except oligoasthenzoospermia),<br> with abnormalities judged clinically significant by the investigator.<br><br> 6. Subjects who are allergic to any component of the experimental drug or biological<br> agent, or who, in the judgment of the investigator, are at risk of allergy as a<br> result of participation in the study.<br><br> 7. Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis<br> C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test<br> (primary screening).<br><br> 8. Tattoos at the injection site or other skin conditions that interfere with<br> observation of the skin.<br><br> 9. Subjects who have smoked more than 5 cigarettes per day or an equivalent amount of<br> tobacco in the 3 months prior to screening.<br><br> 10. Subjects with frequent alcohol consumption within 6 months prior to screening, i.e.,<br> more than 2 units of alcohol per day (1 unit = 360 ml of beer or 45 ml of spirits of<br> 40% alcohol by volume or 150 ml of wine); or those with a positive alcohol breath<br> test.<br><br> 11. Subjects who have habitual consumption of more than 5 cups of coffee, tea or cola,<br> etc. per day (150 ml and above per cup) in the 3 months prior to screening.<br><br> 12. Subjects who have a history of drug abuse within 1 year prior to screening or have a<br> positive urine drug test.<br><br> 13. Subjects who have participated in blood donation within 3 months prior to screening<br> with a total blood donation of = 400 mL or total blood loss of = 400 mL, or who have<br> history of blood transfusion within 4 weeks prior to enrollment.<br><br> 14. Subjects who have taken any investigational product or participated in any clinical<br> trial of drug, devices or vaccines intervention within 3 months prior to screening.<br><br> 15. Vaccination within 1 month prior to screening or scheduled to be administered during<br> the study period up to 2 months after completion of the study.<br><br> 16. Subjects who have used any prescription, over-the-counter medications or herbal<br> remedies within 14 days prior to screening.<br><br> 17. Subjects with a history of fear of needles and homophobia.<br><br> 18. Subjects with other factors that are not suitable for participation in this study as<br> judged by the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of treatment-related adverse events as assessed by CTCAE 5.0
- Secondary Outcome Measures
Name Time Method Maximum Concentration (Cmax);Area under the plasma concentration-time curve (AUC0-t);Area under the curve from time 0 extrapolated to infinite time (AUC0-8);Time to peak Concentration (Tmax);Elimination Phase Half-life (t1/2);apparent oral clearance (CL/F);Anti-drug antibody(ADA)