About this trial
The objective of this clinical trial is to evaluate the safety and tolerability of BY002 in healthy subjects.
Investigators will compare BY002 to a placebo (a pharmacologically inactive substance) to assess the safety and tolerability of BY002 in healthy subjects.
Participants will undergo:
1. Single/multiple subcutaneous (SC) administrations of BY002/placebo 2. A 7-day safety follow-up period following the last dose
Eligibility criteria
Qualifiers
1. Male or female aged ≥18 years at the time of signing the Informed Consent Form (ICF).
Disqualifiers
1. Individuals with a history or current presence of clinically significant cardiovascular (e.g., hypertension), pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatologic, psychiatric, systemic, ocular, reproductive, otorhinolaryngological, dermatological, or infectious diseases, or acute disease signs, unless deemed not clinically significant by the investigator and sponsor.
Trial design
Treatments tested in this trial
- BY002
- Placebo
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
First Affiliated Hospital of Zhejiang University
Lead sponsor
SDM Bioservices Inc.
Collaborator
Beijing Hikinge Pharmaceutical Technology Co., Ltd.
Collaborator
Biyopharma Co., LTD,Hangzhou, China
Collaborator