Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.

NCT07377175 | Recruiting Phase 1

• 1 other identifier: BSY001-202401
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smallpox; Cowpox; Monkeypox; Poxvirus Infection

Outcome Measures

Primary Outcomes (20)

• Safety and Tolerability Parameters (SAD) - TEAE

  Number and percentage of TEAE

  10 days

• Safety and Tolerability (SAD) - Lab tests

  Lab tests (complete blood count, serum biochemistry, and coagulation parameters) at baseline compared to Lab tests 4 days and 10 days post dose.

  Day 4 and day 10 post dose

• Safety and Tolerability (SAD) - Physical Examination

  Physical Examination at Baseline Compared to Physical Examination 4,10 Days Post Dose

  Day 4 and Day 10

• Safety and Tolerability Parameters (SAD) - Vital Signs

  Vital signs at baseline compared to Vital signs (temperature, blood pressure, pulse, breath) day 1 pre dose, day 1, 2, 3, 4, and 10 post dose

  Day 1 pre dose; Day 1, 2, 3, 4, and 10 post dose

• Safety and Tolerability (SAD) - Electrocardiogram

  Electrocardiogram at Baseline Compared to Electrocardiogram day 1 pre dose, 1, 4, 10 Days Post Dose

  Day 1 pre dose, Day 1, 4, 10 post dose

• Pharmacokinetics (MAD) - Cmax

  Maximum observed plasma drug concentration.

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - Cmax,ss

  Steady-state peak plasma concentration

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - Cmin,ss

  Steady-state trough plasma concentration

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - Ctrough,ss

  Steady-state trough concentration

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - Tmax

  Time to peak concentration

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - Tmax,ss

  Steady-state time to peak concentration

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - AUC0-t

  Area under the plasma concentration-time curve from time 0 to the last measurable concentration

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - AUC0-∞

  Area under the plasma concentration-time curve from time 0 extrapolated to infinity

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - AUC0-12h, AUC0-24h

  Area under the plasma concentration-time curve from 0 to 12 hours and 0 to 24 hours

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - t½,z

  Terminal elimination half-life

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - λz

  Terminal elimination rate constant

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - CLz

  Clearance

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - Vz

  Apparent volume of distribution

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - RCmax

  Accumulation ratio based on Cmax

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

• Pharmacokinetics (MAD) - RAUC

  Accumulation ratio based on AUC

  Day 1/14 (1st/2nd dose): Within 30 min pre-dose; 0.5, 1, 2, 4, 6 ,6.5, 8, 9, 10, 12 hours post-dose. Day 4, 6, 12, 13: Within 30 min before daily first dose. 24, 48, 72, 96, 120, 144 hours after the first dose on Day 14.

Secondary Outcomes (15)

• Pharmacokinetics (SAD) - Cmax

  Before administration (within 0.5 hours); and at 0.5, 1, 2, 4, 6 (immediately post-dosing), 6.5, 8, 9, 10, 12, 16, 24, 48, and 72 hours after administration.

• Pharmacokinetics (SAD) - Tmax

  Before administration (within 0.5 hours); and at 0.5, 1, 2, 4, 6 (immediately post-dosing), 6.5, 8, 9, 10, 12, 16, 24, 48, and 72 hours after administration.

• Pharmacokinetics (SAD) - AUC0-t

  Before administration (within 0.5 hours); and at 0.5, 1, 2, 4, 6 (immediately post-dosing), 6.5, 8, 9, 10, 12, 16, 24, 48, and 72 hours after administration.

• Pharmacokinetics (SAD) - AUC0-∞

  Before administration (within 0.5 hours); and at 0.5, 1, 2, 4, 6 (immediately post-dosing), 6.5, 8, 9, 10, 12, 16, 24, 48, and 72 hours after administration.

• Pharmacokinetics - AUC0-12h

  Before administration (within 0.5 hours); and at 0.5, 1, 2, 4, 6 (immediately post-dosing), 6.5, 8, 9, 10, 12, 16, 24, 48, and 72 hours after administration.

Study Arms (6)

SAD Cohort 1

EXPERIMENTAL

A single dose of 37.5mg BSY001 for injection or placebo administered, with 6 subjects receiving BSY001 for injection and 2 subjects receiving the placebo

Drug: BSY001 for Injection (37.5mg); Drug: placebo-SAD

SAD Cohort 2

EXPERIMENTAL

A single dose of 75 mg BSY001 for injection or placebo administered, with 6 subjects receiving BSY001 for injection and 2 subjects receiving the placebo

Drug: BSY001 for Injection (75 mg); Drug: placebo-SAD

SAD Cohort 3

EXPERIMENTAL

A single dose of 150 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo

Drug: BSY001 for Injection (150 mg); Drug: placebo-SAD

SAD Cohort 4

EXPERIMENTAL

A single dose of 200 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo

Drug: BSY001 for Injection (200 mg); Drug: placebo-SAD

SAD Cohort 5

EXPERIMENTAL

A single dose of 300 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo

Drug: BSY001 for Injection (300 mg); Drug: placebo-SAD

MAD Cohort

EXPERIMENTAL

Administer 200 mg of BSY001 or placebo every 12 hours for 14 consecutive days. Among them, 24 subjects will receive BSY001 for injection, and the other 6 subjects will receive placebo.

Drug: BSY001 for Injection; Drug: placebo-MAD

Interventions

BSY001 for Injection (37.5mg) DRUG

A single dose of 37.5mg BSY001 for injection.

SAD Cohort 1

BSY001 for Injection (75 mg) DRUG

A single dose of 75 mg BSY001 for injection.

SAD Cohort 2

BSY001 for Injection (150 mg) DRUG

A single dose of 150 mg BSY001 for injection.

SAD Cohort 3

BSY001 for Injection (200 mg) DRUG

A single dose of 200 mg BSY001 for injection.

SAD Cohort 4

BSY001 for Injection (300 mg) DRUG

A single dose of 300 mg BSY001 for injection.

SAD Cohort 5

placebo-SAD DRUG

A single dose for injection.

SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5

BSY001 for Injection DRUG

Administer 200 mg of BSY001 every 12 hours for 14 consecutive days.

MAD Cohort

placebo-MAD DRUG

Administer placebo every 12 hours for 14 consecutive days.

MAD Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects 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 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);
• 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.

You may not qualify if:

• 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);
• 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);
• Subjects with a creatinine clearance rate (Cockcroft-Gault formula) \< 90 mL/min;
• Subjects with clinically significant abnormalities in physical examination, vital signs, laboratory tests, or other auxiliary examinations as determined by the investigator;
• 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);
• Subjects with a current or history (within the past 3 months) of bacterial, fungal, or mycobacterial infection.;
• Subjects with known clinically significant acute/chronic viral infections;
• Subjects with a history of severe headache or migraine;
• 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;
• Subjects who have donated blood or had massive blood loss (\> 450 mL) within 3 months before screening;
• 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;
• 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;
• 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;
• Subjects who plan to engage in strenuous exercise during the trial, including contact sports or collision sports;
• 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;

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Shulan (Hangzhou) Hospital: collaborator

Study Sites (1)

Shulan (Hangzhou) Hospital

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Smallpox; Cowpox; Mpox, Monkeypox; Poxviridae Infections

Interventions

Injections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Wei Wang

CONTACT

+86-010-60963099; nvsiclinicaltrials@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 29, 2026
• Study Start: August 28, 2025
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)