SmallpoxPhase 1NCT07377175

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

A Phase 1 study testing BSY001 for Injection (37.5mg), BSY001 for Injection (75 mg) and BSY001 for Injection (150 mg) in people with Smallpox and Cowpox, run by China National Biotec Group Company Limited at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Smallpox, Cowpox, Monkeypox
What is being tested?: BSY001 for Injection (37.5mg), BSY001 for Injection (75 mg) and BSY001 for Injection (150 mg)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteChina
Study dates: 28 Aug 2025to 13 Feb 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.;

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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;
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);
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);
Subjects who took any prescription drugs, over-the-counter drugs, or traditional Chinese herbal medicines within 30 days before screening;
Subjects with a positive pregnancy test result;
Subjects who cannot tolerate venipuncture, or have a history of hematophobia (fear of blood) or trypanophobia (fear of needles);
Subjects who developed an acute illness or required concomitant medication from the screening phase to before the first drug administration;
Subjects who received a vaccine within 2 weeks before screening, or plan to receive a vaccine during the trial;
Subjects deemed unsuitable for participation in this trial by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Wang contact

+86-010-60963099

nvsiclinicaltrials@163.com

China1 site, 1 recruiting

Shulan (Hangzhou) Hospital
Hangzhou
Guiling Chen, +86-18343113983, chenguiling707@126.com
Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

This study is divided into two parts: a single-dose study (BSY001-A) and a multiple-dose study (BSY001-B). Subjects for BSY001-B will be enrolled only after all subjects participating in BSY001-A have completed the pharmacokinetic (PK) tests and safety follow-ups for all dose groups, and the corresponding PK parameters and preliminary safety results have been obtained.

BSY001-A: A single ascending dose study conducted in healthy subjects. The trial includes five dose groups: 37.5, 75, 150, 200, and 300 mg, starting from the low-dose group. A total of 46 subjects are planned for enrollment. For the 37.5 mg and 75 mg dose groups, 8 subjects will be enrolled in each group, with 6 receiving BSY001 for injection and 2 receiving placebo. For the 150 mg, 200 mg, and 300 mg dose groups, 10 subjects will be enrolled in each group, including 8 receiving BSY001 for injection and 2 receiving placebo. All subjects will receive a single administration of either BSY001 for injection or placebo. PK blood samples will be collected both prior to and after the initiation of dosing. Subjects who complete PK blood sampling and safety follow-ups may be discontinued from the study. Tolerability assessment will be performed on Day 4 for each dose group, and dosing of the next dose group may commence only after the Safety Monitoring Committee (SMC) confirms safety and tolerability.

BSY001-B: A randomized, double-blind, multiple-dose pharmacokinetic study conducted in healthy subjects. A total of 30 eligible subjects will be enrolled after screening, including 24 in the treatment group and 6 in the placebo group. Subjects will receive 200 mg of BSY001 for injection or placebo, administered once every 12 hours ± 10 minutes for 14 consecutive days. During hospitalization, subjects will be under centralized management by the study center, with blood sample collection and safety assessments performed as scheduled.

Conditions: Smallpox, Cowpox, Monkeypox, Poxvirus Infection
Being tested: BSY001 for Injection (37.5mg), BSY001 for Injection (75 mg), BSY001 for Injection (150 mg), BSY001 for Injection (200 mg), BSY001 for Injection (300 mg)
Medical subject headings: Smallpox, Cowpox, Mpox, Monkeypox, Poxviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BSY001 for Injection (37.5mg)Drug
A single dose of 37.5mg BSY001 for injection.
BSY001 for Injection (75 mg)Drug
A single dose of 75 mg BSY001 for injection.
BSY001 for Injection (150 mg)Drug
A single dose of 150 mg BSY001 for injection.
BSY001 for Injection (200 mg)Drug
A single dose of 200 mg BSY001 for injection.
BSY001 for Injection (300 mg)Drug
A single dose of 300 mg BSY001 for injection.
placebo-SADDrug
A single dose for injection.
BSY001 for InjectionDrug
Administer 200 mg of BSY001 every 12 hours for 14 consecutive days.
placebo-MADDrug
Administer placebo every 12 hours for 14 consecutive days.

Study groups in NCT07377175
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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. Receives: Drug: BSY001 for Injection; Drug: placebo-MAD

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability Parameters (SAD) - TEAE
Number and percentage of TEAE
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 pre dose, Day 1, 4, 10 post dose
Pharmacokinetics (MAD) - Cmax
Maximum observed plasma drug concentration.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Maximum observed plasma drug concentration 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.
Measured: 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
Time to reach 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.
Measured: 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
Area under the plasma concentration vs. time curve (AUC) from time 0 to the last quantifiable measurement. Samples were collected 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.
Measured: 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-∞
AUC from time 0 extrapolated to infinity
Measured: 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
Area under the plasma concentration vs. time curve (AUC) from time 0 to the 12-hour time-point
Measured: 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) - AUC0-24h
Area under the plasma concentration vs. time curve (AUC) from time 0 to the 24-hour time-point
Measured: 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) - t1/2 z
Terminal elimination half-life
Measured: 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) - λz
Terminal elimination rate constant
Measured: 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) - CLz
Apparent total body clearance
Measured: 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) - Vz
Apparent volume of distribution
Measured: 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.
Safety (MAD) - TEAE
Number and percentage of TEAE
Measured: 20 days
Safety (MAD) - Lab tests
Lab tests (complete blood count, serum biochemistry, and coagulation parameters) at baseline compared to Lab tests at day 2~6, day 7 and day 14, day 20.
Measured: day 2~6, day 7 and day 14, day 20.
Safety (MAD) - Physical Examination
Physical Examination at Baseline Compared to Physical Examination at day 20
Measured: Day 20
Safety (MAD) - Electrocardiogram
Electrocardiogram at Baseline Compared to Electrocardiogram 1 day pre dose, day 1, 2~6, 7, 14, 20.
Measured: 1 day pre dose, day 1, 2~6, 7, 14, 20.
Safety (MAD) - Vital Signs
Vital signs at baseline compared to Vital signs (temperature, blood pressure, pulse, breath) day 1 pre dose, day 1, 2~6, 7,8~13, 14, and 20
Measured: day 1 pre dose, day 1, 2~6, 7,8~13, 14, and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 202513 Feb 2026

First posted29 Jan 2026
Study start28 Aug 2025
Primary completion13 Feb 2026 (estimated)
Study completion13 Feb 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SmallpoxStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 76 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07377175
Sponsor's protocol ID: BSY001-202401
Status last verified: Jan 2026
First submitted: 9 Jan 2026
Last updated: 29 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Wei Wang

+86-010-60963099

nvsiclinicaltrials@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Smallpox trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT07377175
Acronym / sponsor ID: BSY001-202401
Conditions: Smallpox, Cowpox, Monkeypox, Poxvirus Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 76 participants (estimated)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Beijing Institute of Biological Products Co Ltd., Shulan (Hangzhou) Hospital
Study start: 28 Aug 2025 (actual)
Primary completion: 13 Feb 2026 (estimated)
Study completion: 13 Feb 2026 (estimated)
First posted: 29 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
SAD Cohort 1	Experimental	Drug: BSY001 for Injection (37.5mg), Drug: placebo-SADA single dose of 37.5mg BSY001 for injection or placebo administered, with 6 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
SAD Cohort 2	Experimental	Drug: BSY001 for Injection (75 mg), Drug: placebo-SADA single dose of 75 mg BSY001 for injection or placebo administered, with 6 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
SAD Cohort 3	Experimental	Drug: BSY001 for Injection (150 mg), Drug: placebo-SADA single dose of 150 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
SAD Cohort 4	Experimental	Drug: BSY001 for Injection (200 mg), Drug: placebo-SADA single dose of 200 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
SAD Cohort 5	Experimental	Drug: BSY001 for Injection (300 mg), Drug: placebo-SADA single dose of 300 mg BSY001 for injection or placebo administered, with 8 subjects receiving BSY001 for injection and 2 subjects receiving the placebo
MAD Cohort	Experimental	Drug: BSY001 for Injection, Drug: placebo-MADAdminister 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (23 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BSY001 for Injection (37.5mg)A single dose of 37.5mg BSY001 for injection.	Drug	SAD Cohort 1
BSY001 for Injection (75 mg)A single dose of 75 mg BSY001 for injection.	Drug	SAD Cohort 2
BSY001 for Injection (150 mg)A single dose of 150 mg BSY001 for injection.	Drug	SAD Cohort 3
BSY001 for Injection (200 mg)A single dose of 200 mg BSY001 for injection.	Drug	SAD Cohort 4
BSY001 for Injection (300 mg)A single dose of 300 mg BSY001 for injection.	Drug	SAD Cohort 5
placebo-SADA single dose for injection.	Drug	SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5
BSY001 for InjectionAdminister 200 mg of BSY001 every 12 hours for 14 consecutive days.	Drug	MAD Cohort
placebo-MADAdminister placebo every 12 hours for 14 consecutive days.	Drug	MAD Cohort

Primary outcome

Safety and Tolerability Parameters (SAD) - TEAE
Time frame: 10 days
Number and percentage of TEAE
Safety and Tolerability (SAD) - Lab tests
Time frame: Day 4 and day 10 post dose
Lab tests (complete blood count, serum biochemistry, and coagulation parameters) at baseline compared to Lab tests 4 days and 10 days post dose.
Safety and Tolerability (SAD) - Physical Examination
Time frame: Day 4 and Day 10
Physical Examination at Baseline Compared to Physical Examination 4,10 Days Post Dose
Safety and Tolerability Parameters (SAD) - Vital Signs
Time frame: Day 1 pre dose; Day 1, 2, 3, 4, and 10 post dose
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
Safety and Tolerability (SAD) - Electrocardiogram
Time frame: Day 1 pre dose, Day 1, 4, 10 post dose
Electrocardiogram at Baseline Compared to Electrocardiogram day 1 pre dose, 1, 4, 10 Days Post Dose
Pharmacokinetics (MAD) - Cmax
Time frame: 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.
Maximum observed plasma drug concentration.
Pharmacokinetics (MAD) - Cmax,ss
Time frame: 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.
Steady-state peak plasma concentration
Pharmacokinetics (MAD) - Cmin,ss
Time frame: 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.
Steady-state trough plasma concentration
Pharmacokinetics (MAD) - Ctrough,ss
Time frame: 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.
Steady-state trough concentration
Pharmacokinetics (MAD) - Tmax
Time frame: 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.
Time to peak concentration
Pharmacokinetics (MAD) - Tmax,ss
Time frame: 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.
Steady-state time to peak concentration
Pharmacokinetics (MAD) - AUC0-t
Time frame: 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.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration
Pharmacokinetics (MAD) - AUC0-∞
Time frame: 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.
Area under the plasma concentration-time curve from time 0 extrapolated to infinity
Pharmacokinetics (MAD) - AUC0-12h, AUC0-24h
Time frame: 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.
Area under the plasma concentration-time curve from 0 to 12 hours and 0 to 24 hours
Pharmacokinetics (MAD) - t½,z
Time frame: 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.
Terminal elimination half-life
Pharmacokinetics (MAD) - λz
Time frame: 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.
Terminal elimination rate constant
Pharmacokinetics (MAD) - CLz
Time frame: 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.
Clearance
Pharmacokinetics (MAD) - Vz
Time frame: 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.
Apparent volume of distribution
Pharmacokinetics (MAD) - RCmax
Time frame: 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.
Accumulation ratio based on Cmax
Pharmacokinetics (MAD) - RAUC
Time frame: 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.
Accumulation ratio based on AUC

15 secondary outcomes

Pharmacokinetics (SAD) - Cmax
Time frame: 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
Time frame: 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
Time frame: 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-∞
Time frame: 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
Time frame: 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) - AUC0-24h
Time frame: 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) - t1/2 z
Time frame: 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) - λz
Time frame: 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) - CLz
Time frame: 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) - Vz
Time frame: 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.
Safety (MAD) - TEAE
Time frame: 20 days
Safety (MAD) - Lab tests
Time frame: day 2~6, day 7 and day 14, day 20.
Safety (MAD) - Physical Examination
Time frame: Day 20
Safety (MAD) - Electrocardiogram
Time frame: 1 day pre dose, day 1, 2~6, 7, 14, 20.
Safety (MAD) - Vital Signs
Time frame: day 1 pre dose, day 1, 2~6, 7,8~13, 14, and 20

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Wei Wang contact

+86-010-60963099

nvsiclinicaltrials@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Wang (+86-010-60963099, nvsiclinicaltrials@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability Parameters (SAD) - TEAE (time frame: 10 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07377175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.