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Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

NCT07282145 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

  • Essential Hypertension

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Bichedam Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2025-09-23
Completion
2026-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282145 on ClinicalTrials.gov