Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Essential Hypertension
In brief
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.
Key facts
- Study ID
- NCT07282145
- Run by
- Bichedam Co., Ltd.
- People needed
- 56
- Starts
- 2025-09-11
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2025-12-15
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (enrolling)
Full record on ClinicalTrials.gov
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