drugset / Trial / NCT07640438
Healthy Participants Randomized, Double-blind, Placebo-controlled, Phase Ⅰ
Phase 1
Recruiting
104 enrolled
First Affiliated Hospital of Zhejiang University
Beijing Hikinge Pharmaceutical Technology Co., Ltd. · collabBiyopharma Co., LTD,Hangzhou, China · collabSDM Bioservices Inc. · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
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
Timeline
- Start
- 2026-06-01
- Primary completion
- 2026-11-30
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BY002 | Unknown | 10 mg | Subcutaneous |
| Subject | BY002 | Unknown | 25 mg | Subcutaneous |
| Subject | BY002 | Unknown | 50 mg | Subcutaneous |
| Subject | BY002 | Unknown | 100 mg | Subcutaneous |
| Subject | BY002 | Unknown | 150 mg | Subcutaneous |
| Subject | BY002 | Unknown | 200 mg | Subcutaneous |
Indications
No indication recorded.