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

ConditionsSmallpoxCowpoxMonkeypoxPoxvirus Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorChina National Biotec Group Company Limited

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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-SAD

    Drug

    A single dose for injection.

  • BSY001 for Injection

    Drug

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

  • placebo-MAD

    Drug

    Administer placebo every 12 hours for 14 consecutive days.

Treatment groups

76 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: SAD Cohort 1Experimental treatment 2 interventions
Group B: SAD Cohort 2Experimental treatment 2 interventions
Group C: SAD Cohort 3Experimental treatment 2 interventions
Group D: SAD Cohort 4Experimental treatment 2 interventions
Group E: SAD Cohort 5Experimental treatment 2 interventions
Group F: MAD CohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Tolerability Parameters (SAD) - TEAE

Number and percentage of TEAE

Time frame
10 days
2

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.

Time frame
Day 4 and day 10 post dose
3

Safety and Tolerability (SAD) - Physical Examination

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

Time frame
Day 4 and Day 10
4

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

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

Secondary outcomes

1

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.

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.
2

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.

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.
3

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.

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.
4

Pharmacokinetics (SAD) - AUC0-∞

AUC from time 0 extrapolated to infinity

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Biotec Group Company Limited

Lead sponsor

Beijing Institute of Biological Products Co Ltd.

Collaborator

Shulan (Hangzhou) Hospital

Collaborator

Source ClinicalTrials.gov
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