RecruitingPhase 1

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

China76 participantsStarted 2025-08-28

Plain-language 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

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕

What they're measuring

Safety and Tolerability Parameters (SAD) - TEAE

Timeframe: 10 days

Safety and Tolerability (SAD) - Lab tests

Timeframe: Day 4 and day 10 post dose

Safety and Tolerability (SAD) - Physical Examination

Timeframe: Day 4 and Day 10

Safety and Tolerability Parameters (SAD) - Vital Signs

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

Safety and Tolerability (SAD) - Electrocardiogram

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

Pharmacokinetics (MAD) - Cmax

Timeframe: 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

Trial details

NCT IDNCT07377175

SponsorChina National Biotec Group Company Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-13

Contact for this trial

Wei Wang

+86-010-60963099 nvsiclinicaltrials@163.com

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