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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants With Adverse Events (Single-Ascending Dose, SAD)
Timeframe: Day -1, Day 1, post-study visit (Day 4-7)
Physical Examination Abnormalities (SAD)
Timeframe: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Vital signs: Systolic and Diastolic Blood Pressure (SAD)
Timeframe: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Vital signs: Heart Rate (SAD)
Timeframe: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Vital signs: Body Temperature (SAD)
Timeframe: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Electrocardiogram (ECG) Abnormalities (SAD)
Timeframe: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Laboratory Abnormalities (SAD)
Timeframe: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Number of Participants With Adverse Events (MAD)
Timeframe: Day -1 through Day 7, and post-study visit (Day 8-12)
Physical Examination Abnormalities (MAD)
Timeframe: Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)
Vital signs: Systolic and Diastolic Blood Pressure (MAD)
Timeframe: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Vital signs: Heart Rate (MAD)
Timeframe: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Vital signs: Body Temperature (MAD)
Timeframe: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Electrocardiogram (ECG) Abnormalities (MAD)
Timeframe: Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)
Laboratory Abnormalities (MAD)
Timeframe: Screening, Day -1, Day 1, Day 6-7, post-study visit (Day 8-12)