Health Trials

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

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

Treatments tested in this trial

  • 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)
  • placebo-SAD
  • BSY001 for Injection
  • placebo-MAD

Treatment groups

76 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

China National Biotec Group Company Limited

Lead sponsor

Beijing Institute of Biological Products Co Ltd.

Collaborator

Shulan (Hangzhou) Hospital

Collaborator

Source ClinicalTrials.gov