Essential HypertensionPhase 1NCT07282145

Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

A Phase 1 study testing BCD101 Low Dose Liquid Formulation, BCD101 High Dose Liquid Formulation and BCD101 Low + High Dose Liquid Formulation in people with Essential Hypertension, run by Bichedam Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Essential Hypertension
What is being tested?: BCD101 Low Dose Liquid Formulation, BCD101 High Dose Liquid Formulation and BCD101 Low + High Dose Liquid Formulation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteSouth Korea
Study dates: 22 Sep 2025to 15 May 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Inclusion Criteria

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.

Exclusion Criteria

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
Pulse rate ≤ 40 bpm or ≥ 100 bpm
Evidence of orthostatic hypotension at screening.
Use of enzyme-inducing or inhibiting drugs such as barbiturates within 1 month prior to first dosing.
Abnormal diet or consumption of foods that could affect drug absorption, distribution, metabolism, or excretion.
Use of prescription or herbal medications that may affect the investigational product's characteristics within 2 weeks prior to first dosing, or over-the-counter drugs or dietary supplements within 10 days prior to first dosing (except when judged by the investigator not to affect the pharmacokinetics of the investigational product).
Participation in another clinical trial with investigational drug administration within 6 months prior to first dosing (the end date of participation is calculated as the day after the last dose of the previous trial).
Whole blood donation within 2 months prior to first dosing, platelet donation within 1 month prior to first dosing, blood transfusion within 1 month prior to first dosing, or inability to abstain from blood donation from informed consent to PSV.
Excessive alcohol consumption (more than 21 units per week; 1 unit = 10 g = 12.5 mL pure alcohol) within 6 months prior to first dosing or inability to abstain from alcohol from informed consent to PSV.
Smoking more than 10 cigarettes per day within 3 months prior to first dosing or inability to abstain from smoking from 24 hours prior to first dosing until last blood sampling.
Consumption of grapefruit-containing foods within 72 hours prior to first dosing or inability to abstain until PSV.
Consumption of caffeine-containing foods or beverages (e.g., coffee, green tea, black tea, carbonated drinks, coffee milk, energy drinks) from 24 hours prior to first dosing until last blood sampling or inability to abstain.
Engaging in strenuous exercise exceeding daily activity levels from 48 hours prior to first dosing until PSV or inability to refrain from such exercise.
Planning to become pregnant or not using reliable contraception methods (e.g., hormonal contraceptives, intrauterine device, sterilization procedures, barrier methods) for self or partner from informed consent until 90 days after last dose of investigational product.
Any other reasons deemed by the investigator to make the subject unsuitable for participation.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644

Other trials in South Korea

About this study

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

The primary objectives of this study are to determine:

The safety and tolerability of BCD101 in healthy adult volunteers.
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:

Administration of single and multiple escalating doses of BCD101 and placebo under controlled conditions.
Safety and tolerability assessments, including monitoring for adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious adverse drug reactions (SADRs).
Pharmacokinetic (PK) analysis to evaluate the pharmacokinetic characteristics of the investigational product.

Conditions: Essential Hypertension
Being tested: BCD101 Low Dose Liquid Formulation, BCD101 High Dose Liquid Formulation, BCD101 Low + High Dose Liquid Formulation, BCD101 Placebo Liquid Formulation
Medical subject headings: Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCD101 Low Dose Liquid FormulationDrug
[SAD] A liquid formulation of BCD101-1 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 BCD101-1 containing 2 g of the active ingredient per 10 g sachet, administered orally. Used for multiple dosing at low concentration.
BCD101 High Dose Liquid FormulationDrug
[SAD] A liquid formulation of BCD101-2 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 BCD101-2 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 FormulationDrug
[MAD] A combination of BCD101-1(2 g) and BCD101-2(4 g) liquid formulations, administered orally as separate sachets simultaneously. Used for multiple dosing.
BCD101 Placebo Liquid FormulationDrug
[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.

Study groups in NCT07282145
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial. Receives: 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial. Receives: 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial. Receives: 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. Receives: 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial. Receives: Drug: BCD101 Placebo Liquid Formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (11)

Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)
Cmax will be determined from the plasma concentration-time profile following a single ascending dose of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) (SAD)
AUC0-t will be calculated using non-compartmental analysis following a single ascending dose of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) (SAD)
AUCinf will be calculated using non-compartmental analysis from the plasma concentration-time profile following a single ascending dose of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) (SAD)
Tmax will be determined from the plasma concentration-time profile following a single ascending dose of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) (SAD)
Terminal elimination half-life will be estimated from the terminal phase of the plasma concentration-time profile following a single ascending dose of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)
Cmax,ss will be determined from the plasma concentration-time profile at steady state following multiple ascending doses of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)
AUCtau,ss will be calculated at steady state during multiple ascending dosing (Day 1-7).
Measured: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to Infinity at Steady State (AUCinf,ss) (MAD)
AUCinf,ss will be calculated using non-compartmental analysis from the plasma concentration-time profile at steady state following multiple ascending doses of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration at Steady State (Tmax,ss) (MAD)
Tmax,ss will be determined from the plasma concentration-time profile at steady state following multiple ascending doses of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)
Terminal elimination half-life at steady state will be estimated from the terminal phase of the plasma concentration-time profile following multiple ascending doses of BCD101.
Measured: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Accumulation Ratio (Rac) (MAD)
Rac will be calculated to assess the accumulation of BCD101 following multiple ascending doses.
Measured: Day 1 (pre-dose through 12 hours post-dose), Day 7 (pre-dose through 12 hours post-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Sep 202515 May 2026

First posted15 Dec 2025
Study start22 Sep 2025
Primary completion15 May 2026
Study completion15 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07282145
Sponsor's protocol ID: BCD101
Status last verified: Sep 2026
First submitted: 17 Nov 2025
Last updated: 29 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07282145
Acronym / sponsor ID: BCD101
Conditions: Essential Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Bichedam Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Sep 2025 (actual)
Primary completion: 15 May 2026 (actual)
Study completion: 15 May 2026 (actual)
First posted: 15 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objectives of this study are to determine:

The safety and tolerability of BCD101 in healthy adult volunteers.
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:

Administration of single and multiple escalating doses of BCD101 and placebo under controlled conditions.
Safety and tolerability assessments, including monitoring for adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious adverse drug reactions (SADRs).
Pharmacokinetic (PK) analysis to evaluate the pharmacokinetic characteristics of the investigational product.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 14

Arm	Type	Receives
SAD-1(Treatment group)	Experimental	Drug: BCD101 Low Dose Liquid Formulation6 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.
SAD-2(Treatment group)	Experimental	Drug: BCD101 High Dose Liquid Formulation6 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.
SAD-3(Treatment group)	Experimental	Drug: BCD101 High Dose Liquid Formulation6 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.
SAD-4(Treatment group)	Experimental	Drug: BCD101 High Dose Liquid Formulation6 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.
MAD-1(Treatment group)	Experimental	Drug: BCD101 Low Dose Liquid Formulation6 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
MAD-2(Treatment group)	Experimental	Drug: BCD101 High Dose Liquid Formulation6 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
MAD-3(Treatment group)	Experimental	Drug: BCD101 Low + High Dose Liquid Formulation6 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
SAD-1(Placebo group)	Experimental	Drug: BCD101 Placebo Liquid Formulation2 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.
SAD-2(Placebo group)	Experimental	Drug: BCD101 Placebo Liquid Formulation2 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.
SAD-3(Placebo group)	Experimental	Drug: BCD101 Placebo Liquid Formulation2 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.
SAD-4(Placebo group)	Experimental	Drug: BCD101 Placebo Liquid Formulation2 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.
MAD-1(Placebo group)	Experimental	Drug: BCD101 Placebo Liquid Formulation2 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.
MAD-2(Placebo group)	Experimental	Drug: BCD101 Placebo Liquid Formulation2 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.
MAD-3(Placebo group)	Experimental	Drug: BCD101 Placebo Liquid Formulation2 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. This study was conducted as a randomized, double-blinded, placebo-controlled, multiple-dose, dose-escalation trial.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BCD101 Low Dose Liquid Formulation[SAD] A liquid formulation of BCD101-1 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 BCD101-1 containing 2 g of the active ingredient per 10 g sachet, administered orally. Used for multiple dosing at low concentration.	Drug	MAD-1(Treatment group), SAD-1(Treatment group)
BCD101 High Dose Liquid Formulation[SAD] A liquid formulation of BCD101-2 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 BCD101-2 containing 4 g of the active ingredient per 10 g sachet, administered orally. Used for multiple dosing at high concentration.	Drug	MAD-2(Treatment group), SAD-2(Treatment group), SAD-3(Treatment group), SAD-4(Treatment group)
BCD101 Low + High Dose Liquid Formulation[MAD] A combination of BCD101-1(2 g) and BCD101-2(4 g) liquid formulations, administered orally as separate sachets simultaneously. Used for multiple dosing.	Drug	MAD-3(Treatment group)
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.	Drug	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)

Primary outcome

Number of Participants With Adverse Events (Single-Ascending Dose, SAD)
Time frame: Day -1, Day 1, post-study visit (Day 4-7)
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.
Physical Examination Abnormalities (SAD)
Time frame: Screening, Day -1, Day 1, post-study visit (Day 4-7)
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.
Vital signs: Systolic and Diastolic Blood Pressure (SAD)
Time frame: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Systolic and diastolic blood pressure will be measured after at least three minutes of rest in the seated position.
Vital signs: Heart Rate (SAD)
Time frame: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Heart rate will be measured after at least three minutes of rest in the seated position.
Vital signs: Body Temperature (SAD)
Time frame: Screening, Day -1, Day 1, post-study visit (Day 4-7)
Body temperature will be measured after at least three minutes of rest in the seated position.
Electrocardiogram (ECG) Abnormalities (SAD)
Time frame: Screening, Day -1, Day 1, post-study visit (Day 4-7)
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.
Laboratory Abnormalities (SAD)
Time frame: Screening, Day -1, Day 1, post-study visit (Day 4-7)
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.
Number of Participants With Adverse Events (MAD)
Time frame: Day -1 through Day 7, and post-study visit (Day 8-12)
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.
Physical Examination Abnormalities (MAD)
Time frame: Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)
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.
Vital signs: Systolic and Diastolic Blood Pressure (MAD)
Time frame: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Systolic and diastolic blood pressure will be measured after at least three minutes of rest in the seated position.
Vital signs: Heart Rate (MAD)
Time frame: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Heart rate will be measured after at least three minutes of rest in the seated position.
Vital signs: Body Temperature (MAD)
Time frame: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)
Body temperature will be measured after at least three minutes of rest in the seated position.
Electrocardiogram (ECG) Abnormalities (MAD)
Time frame: Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)
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.
Laboratory Abnormalities (MAD)
Time frame: Screening, Day -1, Day 1, Day 6-7, post-study visit (Day 8-12)
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.

11 secondary outcomes

Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) (SAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) (SAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration (Tmax) (SAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) (SAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve From Time Zero to Infinity at Steady State (AUCinf,ss) (MAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Time to Maximum Plasma Concentration at Steady State (Tmax,ss) (MAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose), Day 5 (pre-dose), Day 6 (pre-dose), Day 7 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameter: Accumulation Ratio (Rac) (MAD)
Time frame: Day 1 (pre-dose through 12 hours post-dose), Day 7 (pre-dose through 12 hours post-dose)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (Single-Ascending Dose, SAD) (time frame: Day -1, Day 1, post-study visit (Day 4-7)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07282145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.