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Tests treatment safety and results for Smallpox
Official title Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.
ClinicalTrials.gov ID: NCT07377175
What this study is testing
What is BSY001 for Injection (37.5mg)?
BSY001 for Injection (37.5mg) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for smallpox.
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
- A Two-Phase, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 for Injection Following Single or Multiple Doses in Healthy Subjects
- 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. Healthy volunteers may be eligible.
You may be able to join if
- people voluntarily participate in the study, sign the informed consent form, and agree to comply with all study requirements;
- Aged ≥ 18 years and ≤ 50 years (based on the date of signing the informed consent form), including both males and females;
- Body Mass Index (BMI) between 19.0 and 30.0 kg/m² (19.0 and 30.0 kg/m² inclusive); for female people, body weight between 45.0 and 120.0 kg (45.0 kg...
- people (including their partners) voluntarily adopt effective contraceptive measures from 1 month before screening to 6 months after the last...
You likely can't join if
- people with a known allergy to Tecovirimat drugs, any excipient ingredients in this product, or people with an allergic diathesis (allergic to ≥ 2...
- people with clinically significant abnormal electrocardiogram (ECG) findings or QTc prolongation as determined by the investigator (e.g., QTc...
- people with a creatinine clearance rate (Cockcroft-Gault formula) \< 90 mL/min;
- people with clinically significant abnormalities in physical examination, vital signs, laboratory tests, or other auxiliary examinations as...
- people with current or past history of the following clinically significant diseases as determined by the investigator, including but not limited to...
- people with a current or history (within the past 3 months) of bacterial, fungal, or mycobacterial infection.;
See the full eligibility criteria
- people voluntarily participate in the study, sign the informed consent form, and agree to comply with all study requirements;
- Aged ≥ 18 years and ≤ 50 years (based on the date of signing the informed consent form), including both males and females;
- Body Mass Index (BMI) between 19.0 and 30.0 kg/m² (19.0 and 30.0 kg/m² inclusive); for female people, body weight between 45.0 and 120.0 kg (45.0 kg inclusive and 120.0 kg exclusive); for male people, body weight...
- people (including their partners) voluntarily adopt effective contraceptive measures from 1 month before screening to 6 months after the last administration of the study drug, and have no plans for childbearing, sperm...
- people with a known allergy to Tecovirimat drugs, any excipient ingredients in this product, or people with an allergic diathesis (allergic to ≥ 2 types of substances);
- people with clinically significant abnormal electrocardiogram (ECG) findings or QTc prolongation as determined by the investigator (e.g., QTc interval ≥ 450 ms in males and ≥ 470 ms in females, with QTc interval...
- people with a creatinine clearance rate (Cockcroft-Gault formula) \< 90 mL/min;
- people with clinically significant abnormalities in physical examination, vital signs, laboratory tests, or other auxiliary examinations as determined by the investigator;
- people with current or past history of the following clinically significant diseases as determined by the investigator, including but not limited to diseases of the cardiovascular system, respiratory system, digestive...
- people with a current or history (within the past 3 months) of bacterial, fungal, or mycobacterial infection.;
- people with known clinically significant acute/chronic viral infections;
- people with a history of severe headache or migraine;
- people who have undergone major surgery within 6 months before drug administration, or plan to undergo surgery from the time of signing the informed consent form to 1 month after the end of the trial;
- people who have donated blood or had massive blood loss (\> 450 mL) within 3 months before screening;
- people who smoked more than 5 cigarettes per day within 3 months before signing the informed consent form, or cannot refrain from using any tobacco products during the trial;
- people who consumed more than 14 units of alcohol per week within 3 months before signing the informed consent form (1 unit of alcohol ≈ 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine)...
- people who consumed grapefruit, grapefruit juice, chocolate, strong tea, coffee, or other beverages containing caffeine or alcohol within 72 hours before drug administration, or refuse to stop consuming the...
- people who plan to engage in strenuous exercise during the trial, including contact sports or collision sports;
- people with a positive urine drug screen (for morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine, or tetrahydrocannabinolic acid), or a history of drug abuse or drug use within 5 years before...
- people with a positive result in any of the following tests: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (IgG), hepatitis C virus core antigen, human immunodeficiency virus (HIV) antibody, or...
- people who participated in other drug clinical trials within 3 months before screening (calculated starting from the time of the last drug administration in the previous trial);
- people who took any prescription drugs, over-the-counter drugs, or traditional Chinese herbal medicines within 30 days before screening;
- people with a positive pregnancy test result;
- people who cannot tolerate venipuncture, or have a history of hematophobia (fear of blood) or trypanophobia (fear of needles);
- people who developed an acute illness or required concomitant medication from the screening phase to before the first drug administration;
- people who received a vaccine within 2 weeks before screening, or plan to receive a vaccine during the trial;
- people deemed unsuitable for participation in this trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, 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 all sexes, 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 Hangzhou, 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.