RecruitingPhase 1NCT07282145

Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

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

Sponsor

Bichedam Co., Ltd.

Enrollment

56 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Essential Hypertension

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human safety study for a new drug called BCD101, being tested in healthy volunteers to understand how the body absorbs, processes, and tolerates it. **You may be eligible if...** - You are 19 years or older - You weigh at least 50 kg and have a BMI between 18 and 30 - You are generally healthy with no chronic conditions requiring treatment - Your lab tests, vital signs, physical exam, and ECG (heart tracing) are all normal - You fully understand the study and have given written consent **You may NOT be eligible if...** - You have any ongoing medical conditions or take regular medications - Your health screening results show abnormalities - You are pregnant or unable to comply with study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBCD101 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.

DRUGBCD101 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.

DRUGBCD101 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.

DRUGBCD101 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.