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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:
⁃ Healthy adult volunteers aged 19 years or older at screening.
• Body weight ≥ 50.0 kg and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at screening.
⁃ \* BMI (kg/m²) = weight (kg) / {height (m)}²
• No congenital or chronic medical conditions requiring treatment, and no pathological signs or findings upon medical examination.
• Clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram (ECG) results at screening indicate suitability for participation based on the characteristics of the investigational medicinal product.
• Fully understood the detailed explanation of this clinical trial, voluntarily agreed to participate, and provided written informed consent agreeing to comply with study requirements during the trial period.
Locations
Other Locations
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
Contact Information
Primary
Chief Executive Officer
hobin@bichedam.org
+82-10-9326-1804
Time Frame
Start Date:2025-09-11
Estimated Completion Date:2026-04-30
Participants
Target number of participants:56
Treatments
Experimental: SAD-1(Treatment group)
6 Participants in the SAD-1(Treatment group) arm received a single oral dose of BCD101-1(2 sachets).~BCD101-1 is a low-dose liquid formulation containing 2 g of the active ingredient per 10 g sachet.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: SAD-2(Treatment group)
6 Participants in the SAD-2(Treatment group) arm received a single oral dose of BCD101-2(2 sachets).~BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: SAD-3(Treatment group)
6 Participants in the SAD-3(Treatment group) arm received a single oral dose of BCD101-2(3 sachets).~BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: SAD-4(Treatment group)
6 Participants in the SAD-4(Treatment group) arm received a single oral dose of BCD101-2(4 sachets).~BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: MAD-1(Treatment group)
6 Participants in the MAD-1(Treatment group) arm received BCD101-1(1 sachet), administered orally twice daily for 7 consecutive days.~BCD101-1 is a low-dose liquid formulation containing 2 g of the active ingredient per 10 g sachet.~The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Experimental: MAD-2(Treatment group)
6 Participants in the MAD-2(Treatment group) arm received BCD101-2(1 sachet), administered orally twice daily for 7 consecutive days.~BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.~The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Experimental: MAD-3(Treatment group)
6 Participants in the MAD-3(Treatment group) arm received a combination of BCD101-1(1 sachet) and BCD101-2(1 sachet), administered orally twice daily for 7 consecutive days.~BCD101-1 is a low-dose liquid formulation containing 2 g of the active ingredient per 10 g sachet, while BCD101-2 is a high-dose liquid formulation containing 4 g of the active ingredient per 10 g sachet.~The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Experimental: SAD-1(Placebo group)
2 Participants in the SAD-1(Placebo group) arm received a single oral dose of BCD101-P(2 sachets).~BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-1, containing no active ingredient.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: SAD-2(Placebo group)
2 Participants in the SAD-2(Placebo group) arm received a single oral dose of BCD101-P(2 sachets).~BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: SAD-3(Placebo group)
2 Participants in the SAD-3(Placebo group) arm received a single oral dose of BCD101-P(3 sachets).~BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: SAD-4(Placebo group)
2 Participants in the SAD-4(Placebo group) arm received a single oral dose of BCD101-P(4 sachets).~BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.~This study was conducted as a randomized, double-blinded, placebo-controlled, oral, single-dose, dose-escalation trial.
Experimental: MAD-1(Placebo group)
2 Participants in the MAD-1(Placebo group) arm received BCD101-P(1 sachet), administered orally twice daily for 7 consecutive days.~BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-1, containing no active ingredient.~The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Experimental: MAD-2(Placebo group)
2 Participants in the MAD-2(Placebo group) arm received BCD101-P(1 sachet), administered orally twice daily for 7 consecutive days.~BCD101-P is a placebo liquid formulation identical in appearance and volume to BCD101-2, containing no active ingredient.~The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
Experimental: MAD-3(Placebo group)
2 Participants in the MAD-3(Placebo group) arm received BCD101-P(2 sachets), administered orally twice daily for 7 consecutive days.~BCD101-P is a placebo liquid formulation identical in appearance and volume to the active formulations, containing no active ingredient.~The study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.