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 serious adverse events and serious adverse drug reactions (Serious AEs/ADRs).
3. Collection of blood samples for pharmacokinetic analysis.