Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

NCT07282145 | Recruiting Phase 1

• 1 other identifier: BCD101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 1.The safety and tolerability of BCD101 in healthy adult volunteers.
2. 2.The pharmacokinetic profile of BCD101 following single and multiple dosing.
3. 3.Administration of single and multiple escalating doses of BCD101 and placebo under controlled conditions.
4. 4.Safety and tolerability assessments, including monitoring for serious adverse events and serious adverse drug reactions (Serious AEs/ADRs).
5. 5.Collection of blood samples for pharmacokinetic analysis.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (14)

• Number of Participants With Adverse Events (Single-Ascending Dose, SAD)

  All adverse events occurring during the clinical trial following a single ascending dose of BCD101 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product. Events will be coded using MedDRA System Organ Class and Preferred Term. \[Unit of Measure\] Participants

  Day -1, Day 1, post-study visit (Day 4-7)

• Physical Examination Abnormalities (SAD)

  A complete physical examination will be performed, and findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as abnormalities for this outcome measure. Non-clinically significant deviations (NCS) will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported. \[Unit of Measure\] Participants

  Screening, Day -1, Day 1, post-study visit (Day 4-7)

• Vital signs: Systolic and Diastolic Blood Pressure (SAD)

  Systolic and diastolic blood pressure will be measured after at least three minutes of rest in the seated position. \[Unit of Measure\] mmHg

  Screening, Day -1, Day 1, post-study visit (Day 4-7)

• Vital signs: Heart Rate (SAD)

  Heart rate will be measured after at least three minutes of rest in the seated position. \[Unit of Measure\] Beats per minute (bpm)

  Screening, Day -1, Day 1, post-study visit (Day 4-7)

• Vital signs: Body Temperature (SAD)

  Body temperature will be measured after at least three minutes of rest in the seated position. \[Unit of Measure\] °C

  Screening, Day -1, Day 1, post-study visit (Day 4-7)

• Electrocardiogram (ECG) Abnormalities (SAD)

  A standard 12-lead electrocardiogram will be performed, and ECG findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as ECG abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported. \[Unit of Measure\] Participants

  Screening, Day -1, Day 1, post-study visit (Day 4-7)

• Laboratory Abnormalities (SAD)

  Clinical laboratory tests will include hematology, clinical chemistry, urinalysis, serology, and urine drug screening. Laboratory findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as laboratory abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported. \[Unit of Measure\] Participants

  Screening, Day -1, Day 1, post-study visit (Day 4-7)

• Number of Participants With Adverse Events (MAD)

  All adverse events occurring during the clinical trial following a multiple ascending dose of BCD101 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product. Events will be coded using MedDRA System Organ Class and Preferred Term. \[Unit of Measure\] Participants

  Day -1 through Day 7, and post-study visit (Day 8-12)

• Physical Examination Abnormalities (MAD)

  A complete physical examination will be performed, and findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as abnormalities for this outcome measure. Non-clinically significant deviations (NCS) will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported. \[Unit of Measure\] Participants

  Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)

• Vital signs: Systolic and Diastolic Blood Pressure (MAD)

  Systolic and diastolic blood pressure will be measured after at least three minutes of rest in the seated position. \[Unit of Measure\] mmHg

  Screening, Day -1 through Day 7, and post-study visit (Day 8-12)

• Vital signs: Heart Rate (MAD)

  Heart rate will be measured after at least three minutes of rest in the seated position. \[Unit of Measure\] Beats per minute (bpm)

  Screening, Day -1 through Day 7, and post-study visit (Day 8-12)

• Vital signs: Body Temperature (MAD)

  Body temperature will be measured after at least three minutes of rest in the seated position. \[Unit of Measure\] °C

  Screening, Day -1 through Day 7, and post-study visit (Day 8-12)

• Electrocardiogram (ECG) Abnormalities (MAD)

  A standard 12-lead electrocardiogram will be performed, and ECG findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as ECG abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported. \[Unit of Measure\] Participants

  Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)

• Laboratory Abnormalities (MAD)

  Clinical laboratory tests will include hematology, clinical chemistry, urinalysis, serology, and urine drug screening. Laboratory findings will be categorized as normal, not clinically significant (NCS), or clinically significant (CS). Only clinically significant (CS) findings will be classified as laboratory abnormalities for this outcome measure. Non-clinically significant deviations (NCS) from reference ranges will not be classified as abnormalities. The number of participants with clinically significant abnormalities will be reported. \[Unit of Measure\] Participants

  Screening, Day -1, Day 1, Day 6-7, post-study visit (Day 8-12)

Secondary Outcomes (11)

• Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)

  Day 1 (pre-dose through 12 hours post-dose)

• Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-t) (SAD)

  Day 1 (pre-dose through 12 hours post-dose)

• Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)

  Day 1 (pre-dose through 12 hours post-dose)

• Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)

  Day 1 (pre-dose through 12 hours post-dose)

• Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD)

  Day 1 (pre-dose through 12 hours post-dose)

Study Arms (14)

SAD-1(Treatment group)

EXPERIMENTAL

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.

Drug: BCD101 Low Dose Liquid Formulation

SAD-2(Treatment group)

EXPERIMENTAL

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.

Drug: BCD101 High Dose Liquid Formulation

SAD-3(Treatment group)

EXPERIMENTAL

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.

Drug: BCD101 High Dose Liquid Formulation

SAD-4(Treatment group)

EXPERIMENTAL

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.

Drug: BCD101 High Dose Liquid Formulation

MAD-1(Treatment group)

EXPERIMENTAL

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.

Drug: BCD101 Low Dose Liquid Formulation

MAD-2(Treatment group)

EXPERIMENTAL

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.

Drug: BCD101 High Dose Liquid Formulation

MAD-3(Treatment group)

EXPERIMENTAL

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.

Drug: BCD101 Low + High Dose Liquid Formulation

SAD-1(Placebo group)

EXPERIMENTAL

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.

Drug: BCD101 Placebo Liquid Formulation

SAD-2(Placebo group)

EXPERIMENTAL

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.

Drug: BCD101 Placebo Liquid Formulation

SAD-3(Placebo group)

EXPERIMENTAL

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.

Drug: BCD101 Placebo Liquid Formulation

SAD-4(Placebo group)

EXPERIMENTAL

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.

Drug: BCD101 Placebo Liquid Formulation

MAD-1(Placebo group)

EXPERIMENTAL

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.

Drug: BCD101 Placebo Liquid Formulation

MAD-2(Placebo group)

EXPERIMENTAL

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.

Drug: BCD101 Placebo Liquid Formulation

MAD-3(Placebo group)

EXPERIMENTAL

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.

Drug: BCD101 Placebo Liquid Formulation

Interventions

BCD101 Low + High Dose Liquid Formulation DRUG

\[MAD\] A combination of low-dose and high-dose BCD101 liquid formulations, administered orally as separate sachets simultaneously. Used for multiple dosing.

MAD-3(Treatment group)

BCD101 Placebo Liquid Formulation DRUG

\[SAD Placebo\] 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.

MAD-1(Placebo group); MAD-2(Placebo group); MAD-3(Placebo group); SAD-1(Placebo group); SAD-2(Placebo group); SAD-3(Placebo group); SAD-4(Placebo group)

BCD101 Low Dose Liquid Formulation DRUG

\[SAD\] 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.

MAD-1(Treatment group); SAD-1(Treatment group)

BCD101 High Dose Liquid Formulation DRUG

\[SAD\] 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.

MAD-2(Treatment group); SAD-2(Treatment group); SAD-3(Treatment group); SAD-4(Treatment group)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History or current clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematological, neoplastic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal disorders.
• Female subjects who are pregnant (urine hCG positive) or breastfeeding.
• History of hypersensitivity (e.g., anaphylaxis, angioedema) or clinically significant allergic reactions to the active ingredient, excipients of the investigational product, or other medications (e.g., aspirin, penicillin antibiotics, macrolide antibiotics).
• History of gastrointestinal diseases or surgeries that could affect absorption of the investigational drug (e.g., Crohn's disease, ulcers, acute or chronic pancreatitis), except simple appendectomy or hernia surgery.
• Clinically significant abnormalities on 12-lead ECG at screening, including:
• QTc interval \> 450 ms (males) or \> 470 ms (females)
• PR interval \> 200 ms
• QRS duration \> 120 ms
• Clinically significant laboratory abnormalities at screening, including:
• Liver function tests (AST, ALT, ALP, γ-GT, total bilirubin) exceeding twice the upper limit of normal.
• Serum creatinine outside the reference range or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m² as calculated by the CKD-EPI formula.
• History of substance abuse or positive urine drug screening for abuse substances.
• Vital signs at screening after at least 3 minutes of rest in a seated position meet any of the following:
• Systolic blood pressure ≤ 90 mmHg or ≥ 150 mmHg
• Diastolic blood pressure ≤ 60 mmHg or ≥ 100 mmHg

Sponsors & Collaborators

• Bichedam Co., Ltd.: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chief Executive Officer

CONTACT

+82-10-9326-1804; hobin@bichedam.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 15, 2025
• Study Start: September 11, 2025
• Primary Completion: September 23, 2025
• Study Completion: April 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

KR (1)