Safety, tolerability, and how the body processes BSY001 after single and multiple doses

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.

This trial will test whether BSY001 is safe, well tolerated, and how it is absorbed and cleared when given once or multiple times to healthy adults aged 18–50.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: China National Biotec Group Company Limited (Industry-sponsored)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07377175 on ClinicalTrials.gov

What this trial studies

The trial is a randomized, double-blind, placebo-controlled Phase 1 program in healthy volunteers with two parts: a single-ascending-dose part (37.5–300 mg across five groups) and a multiple-dose pharmacokinetic part. About 46 subjects are planned for the single-dose escalation with predefined sentinel and placebo allocations, and 30 subjects will be enrolled in the multiple-dose portion after safety and PK review. Blood samples for pharmacokinetics are collected before and after dosing and tolerability is specifically reviewed (including a Day 4 check) before escalating to the next dose. An independent Safety Monitoring Committee will review PK and safety data between parts and before progression to higher doses or the multiple-dose phase.

Who should consider this trial

Good fit: Healthy men and women aged 18–50 with BMI 19.0–30.0 and within the specified weight ranges who can give informed consent and agree to required contraception are eligible.

Not a fit: People with a known allergy to tecovirimat or formulation excipients, those outside the age or BMI limits, or patients seeking treatment for active poxvirus disease are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BSY001 could become an additional antiviral option for poxvirus infections such as monkeypox and smallpox.

How similar studies have performed: Related antivirals like tecovirimat have shown safety and activity against orthopoxviruses in humans, providing precedent though BSY001 itself is in first-in-human Phase 1 testing.

Eligibility criteria

Inclusion Criteria:

1. Subjects voluntarily participate in the study, sign the informed consent form, and agree to comply with all study requirements;
2. Aged ≥ 18 years and ≤ 50 years (based on the date of signing the informed consent form), including both males and females;
3. Body Mass Index (BMI) between 19.0 and 30.0 kg/m² (19.0 and 30.0 kg/m² inclusive); for female subjects, body weight between 45.0 and 120.0 kg (45.0 kg inclusive and 120.0 kg exclusive); for male subjects, body weight between 50.0 and 120.0 kg (50.0 kg inclusive and 120.0 kg exclusive);
4. Subjects (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 donation, or egg donation within the next 6 months.

Exclusion Criteria:

1. Subjects with a known allergy to Tecovirimat drugs, any excipient ingredients in this product, or subjects with an allergic diathesis (allergic to ≥ 2 types of substances);
2. Subjects 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 calculated using the Fridericia formula);
3. Subjects with a creatinine clearance rate (Cockcroft-Gault formula) \< 90 mL/min;
4. Subjects with clinically significant abnormalities in physical examination, vital signs, laboratory tests, or other auxiliary examinations as determined by the investigator;
5. Subjects 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 system, urinary system, endocrine system, immune system, and nervous system (e.g., epilepsy);
6. Subjects with a current or history (within the past 3 months) of bacterial, fungal, or mycobacterial infection.;
7. Subjects with known clinically significant acute/chronic viral infections;
8. Subjects with a history of severe headache or migraine;
9. Subjects 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;
10. Subjects who have donated blood or had massive blood loss (\> 450 mL) within 3 months before screening;
11. Subjects 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;
12. Subjects 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), had a positive alcohol breath test (breath alcohol content \> 0 mg/100 mL), or cannot abstain from alcohol during the trial;
13. Subjects 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 aforementioned beverages and foods during the trial;
14. Subjects who plan to engage in strenuous exercise during the trial, including contact sports or collision sports;
15. Subjects 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 screening;
16. Subjects 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 treponema pallidum-specific antibody (TP-Ab);
17. Subjects 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);
18. Subjects who took any prescription drugs, over-the-counter drugs, or traditional Chinese herbal medicines within 30 days before screening;
19. Subjects with a positive pregnancy test result;
20. Subjects who cannot tolerate venipuncture, or have a history of hematophobia (fear of blood) or trypanophobia (fear of needles);
21. Subjects who developed an acute illness or required concomitant medication from the screening phase to before the first drug administration;
22. Subjects who received a vaccine within 2 weeks before screening, or plan to receive a vaccine during the trial;
23. Subjects deemed unsuitable for participation in this trial by the investigator.

Where this trial is running

Hangzhou

• Shulan (Hangzhou) Hospital — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Wei Wang

Conditions Smallpox; Cowpox; Monkeypox; Poxvirus Infection