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Tests treatment safety and results for Oligozoospermia
Official title A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects
ClinicalTrials.gov ID: NCT06948799
What this study is testing
What is STSP-0902 injection?
STSP-0902 injection is an investigational medicine, being studied as a potential treatment for oligozoospermia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, men only. Healthy volunteers may be eligible.
You may be able to join if
- Male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a body mass index (BMI) between 19.0 and 28.0...
- Participants in the multiple dose phase must meet one of the following criteria: two routine semen analysis results during the screening period meet...
- Participants (including the partners of the participants) must use effective non-drug contraceptive measures during the trial period and for four...
- Participants should avoid high temperature environments during the trial, including saunas, steam baths, hot baths, hot springs, and the use of...
- Participants must give informed consent to this study before the study and voluntarily sign a written informed consent form.
You likely can't join if
- Participants with a history of severe diseases, including but not limited to conditions affecting the skeletal, neuropsychiatric, cardiovascular...
- Participants who have planned to receive treatments related to oligoasthenzoospermia, such as zinc sulfate, levocarnitine, escin, or pancreatic...
- Participants with a history of treatment with nerve growth factor-like drug therapy (such as mouse nerve growth factor for injection) within 3 months...
- Participants who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
- Participants who have experienced a fever exceeding 38 ℃ within 1 month prior to screening
- Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory tests, and results of all tests related to the trial (except...
See the full eligibility criteria
- Male volunteers, aged between 18 and 50 years inclusive, with a body weight of at least 50.0 kg, and a body mass index (BMI) between 19.0 and 28.0 kg/m² inclusive.
- Participants in the multiple dose phase must meet one of the following criteria: two routine semen analysis results during the screening period meet the criteria of sperm concentration of less than 15 million and/or...
- Participants (including the partners of the participants) must use effective non-drug contraceptive measures during the trial period and for four months after the end of administration, and must not have plans for...
- Participants should avoid high temperature environments during the trial, including saunas, steam baths, hot baths, hot springs, and the use of electric blankets.
- Participants must give informed consent to this study before the study and voluntarily sign a written informed consent form.
- Participants with a history of severe diseases, including but not limited to conditions affecting the skeletal, neuropsychiatric, cardiovascular, hematologic, hepatic, renal, gastrointestinal, respiratory, metabolic...
- Participants who have planned to receive treatments related to oligoasthenzoospermia, such as zinc sulfate, levocarnitine, escin, or pancreatic kallikrein, within 3 months prior to screening or during the trial period.
- Participants with a history of treatment with nerve growth factor-like drug therapy (such as mouse nerve growth factor for injection) within 3 months prior to screening.
- Participants who have undergone any major surgery within 3 months prior to screening or have surgery planned during the trial period.
- Participants who have experienced a fever exceeding 38 ℃ within 1 month prior to screening
- Pre-enrollment physical examination, electrocardiogram, vital signs, laboratory tests, and results of all tests related to the trial (except oligoasthenzoospermia), with abnormalities judged clinically significant by...
- Participants who are allergic to any component of the experimental drug or biological agent, or who, in the judgment of the investigator, are at risk of allergy as a result of participation in the study.
- Participants who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening).
- Tattoos at the injection site or other skin conditions that interfere with observation of the skin.
- Participants who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco in the 3 months prior to screening.
- Participants with frequent alcohol consumption within 6 months prior to screening, i.e., more than 2 units of alcohol per day (1 unit = 360 ml of beer or 45 ml of spirits of 40% alcohol by volume or 150 ml of wine); or...
- Participants who have habitual consumption of more than 5 cups of coffee, tea or cola, etc. per day (150 ml and above per cup) in the 3 months prior to screening.
- Participants who have a history of drug abuse within 1 year prior to screening or have a positive urine drug test.
- Participants who have participated in blood donation within 3 months prior to screening with a total blood donation of ≥ 400 mL or total blood loss of ≥ 400 mL, or who have history of blood transfusion within 4 weeks...
- Participants who have taken any investigational product or participated in any clinical trial of drug, devices or vaccines intervention within 3 months prior to screening.
- Vaccination within 1 month prior to screening or scheduled to be administered during the study period up to 2 months after completion of the study.
- Participants who have used any prescription, over-the-counter medications or herbal remedies within 14 days prior to screening.
- Participants with a history of fear of needles and homophobia.
- Participants with other factors that are not suitable for participation in this study as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.