BCD101 safety and how the body processes it in healthy adults

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

This trial tests if BCD101 is safe and how the body processes it in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Bichedam Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Cheongju-si, North Chungcheong)
• Trial ID: NCT07282145 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1 trial gives single and multiple escalating doses of BCD101 to healthy adult volunteers to characterize safety and pharmacokinetics. Participants are assigned to dose cohorts and compared with placebo under controlled clinic conditions. Blood samples are collected over time to measure drug levels and generate PK profiles while safety labs, ECGs, and adverse events are monitored. The dose-escalation design compares cohorts to identify dose-dependent tolerability and exposure.

Who should consider this trial

Good fit: Healthy adults aged 19 or older with BMI 18.0–30.0 kg/m², weight ≥50 kg, no significant chronic medical conditions, and normal screening labs and ECGs are eligible.

Not a fit: People with active or chronic medical conditions (for example significant liver, kidney, cardiac, neurological, or psychiatric disease) or uncontrolled hypertension are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, the results will define safe dosing and drug behavior in humans to guide later trials that could develop BCD101 as a treatment for hypertension.

How similar studies have performed: Phase 1 safety and pharmacokinetic studies are standard and have enabled many antihypertensive drugs to advance, but BCD101 appears to be undergoing its first human safety/PK assessment and is novel.

Eligibility criteria

1. 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.
2. 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.

Where this trial is running

Cheongju-si, North Chungcheong

• Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (Recruiting)

Study contacts

• Study coordinator: Chief Executive Officer

Conditions Essential Hypertension