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Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers
Sponsor: Bichedam Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-09-11
Completion Date
2026-04-30
Last Updated
2025-12-15
Healthy Volunteers
Yes
Conditions
Interventions
BCD101 Low Dose Liquid Formulation
\[SAD\] A liquid formulation of BCD101 containing 2 g of the active ingredient per 10 g sachet, administered orally. Used for single dosing at low concentration. \[MAD\] A liquid formulation of BCD101 containing 2 g of the active ingredient per 10 g sachet, administered orally. Used for multiple dosing at low concentration.
BCD101 High Dose Liquid Formulation
\[SAD\] A liquid formulation of BCD101 containing 4 g of the active ingredient per 10 g sachet, administered orally. Used for single dosing at high concentration. \[MAD\] A liquid formulation of BCD101 containing 4 g of the active ingredient per 10 g sachet, administered orally. Used for multiple dosing at high concentration.
BCD101 Low + High Dose Liquid Formulation
\[MAD\] A combination of low-dose and high-dose BCD101 liquid formulations, administered orally as separate sachets simultaneously. Used for multiple dosing.
BCD101 Placebo Liquid Formulation
\[SAD Placebo\] A placebo liquid formulation matching the appearance and volume of BCD101 sachets, containing no active ingredient. Administered orally. Used for single dosing. \[MAD Placebo\] A placebo liquid formulation matching the appearance and volume of BCD101 sachets, containing no active ingredient. Administered orally. Used for multiple dosing.
Locations (1)
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea