Actively Recruiting
A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects
Led by Staidson (Beijing) Biopharmaceuticals Co., Ltd · Updated on 2026-04-28
64
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1b, randomized, double-blind, placebo-controlled, single and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902
CONDITIONS
Official Title
A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male volunteers aged 18 to 50 years inclusive
- Body weight of at least 50.0 kg
- Body mass index (BMI) between 19.0 and 28.0 kg/m² inclusive
- For multiple dose phase: two semen analyses during screening with sperm concentration less than 15 million and/or progressive motility less than 32%
- Use effective non-drug contraceptive measures during the trial and for four months after
- No plans for pregnancy or sperm donation during the trial
- Avoid high temperature environments such as saunas, steam baths, hot baths, hot springs, and electric blankets during the trial
- Provide informed consent and voluntarily sign the consent form
You will not qualify if you...
- History of severe diseases affecting major body systems or reproductive system infections except oligoasthenzoospermia
- Planned or recent treatments for oligoasthenzoospermia within 3 months prior or during trial
- Treatment with nerve growth factor-like drugs within 3 months prior to screening
- Major surgery within 3 months prior or planned during trial
- Fever over 38°C within 1 month prior to screening
- Clinically significant abnormalities in physical exams, ECG, vital signs, or lab tests
- Allergy to any component of the study drug or biological agents
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Tattoos or skin conditions at injection site interfering with observation
- Smoking more than 5 cigarettes per day within 3 months prior to screening
- Frequent alcohol consumption exceeding 2 units per day within 6 months prior
- Habitual consumption of more than 5 cups of coffee, tea, or cola per day within 3 months prior
- History of drug abuse within 1 year prior or positive urine drug test
- Blood donation totaling ≥400 mL within 3 months prior or blood transfusion within 4 weeks prior
- Participation in other clinical trials within 3 months prior to screening
- Vaccination within 1 month prior or planned during study until 2 months after completion
- Use of prescription, over-the-counter, or herbal medications within 14 days prior to screening
- History of fear of needles or homophobia
- Other factors judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
B
Bi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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