Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

A randomized, double-blinded, single/multiple dosing, dose escalation Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of BCD101 in healthy adult volunteers. The primary objectives of this study are to determine: 1. The safety and tolerability of BCD101 in healthy adult volunteers. 2. The pharmacokinetic profile of BCD101 following single and multiple dosing. A control group is included, and dose cohorts will be compared to assess dose-dependent differences in safety, tolerability, and pharmacokinetics. Key study activities include: 1. Administration of single and multiple escalating doses of BCD101 and placebo under controlled conditions. 2. Safety and tolerability assessments, including monitoring for adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious adverse drug reactions (SADRs). 3. Pharmacokinetic (PK) analysis to evaluate the pharmacokinetic characteristics of the investigational product.