Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Number of Participants With Adverse Events (Single-Ascending Dose, SAD) [Срок оценки: Day -1, Day 1, post-study visit (Day 4-7)]
• Physical Examination Abnormalities (SAD) [Срок оценки: Screening, Day -1, Day 1, post-study visit (Day 4-7)]
• Vital signs: Systolic and Diastolic Blood Pressure (SAD) [Срок оценки: Screening, Day -1, Day 1, post-study visit (Day 4-7)]
• Vital signs: Heart Rate (SAD) [Срок оценки: Screening, Day -1, Day 1, post-study visit (Day 4-7)]
• Vital signs: Body Temperature (SAD) [Срок оценки: Screening, Day -1, Day 1, post-study visit (Day 4-7)]
• Electrocardiogram (ECG) Abnormalities (SAD) [Срок оценки: Screening, Day -1, Day 1, post-study visit (Day 4-7)]
• Laboratory Abnormalities (SAD) [Срок оценки: Screening, Day -1, Day 1, post-study visit (Day 4-7)]
• Number of Participants With Adverse Events (MAD) [Срок оценки: Day -1 through Day 7, and post-study visit (Day 8-12)]
• Physical Examination Abnormalities (MAD) [Срок оценки: Screening, Day -1, Day 1, Day 7, post-study visit (Day 8-12)]
• Vital signs: Systolic and Diastolic Blood Pressure (MAD) [Срок оценки: Screening, Day -1 through Day 7, and post-study visit (Day 8-12)]

Вторичные конечные точки (11)

• Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD) [Срок оценки: Day 1 (pre-dose through 12 hours post-dose)]
• Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-t) (SAD) [Срок оценки: Day 1 (pre-dose through 12 hours post-dose)]
• Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD) [Срок оценки: Day 1 (pre-dose through 12 hours post-dose)]
• Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD) [Срок оценки: Day 1 (pre-dose through 12 hours post-dose)]
• Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD) [Срок оценки: Day 1 (pre-dose through 12 hours post-dose)]
• Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD) [Срок оценки: 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) [Срок оценки: 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 Extrapolated to Infinity at Steady State (AUCinf,ss) (MAD) [Срок оценки: 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: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD) [Срок оценки: 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: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD) [Срок оценки: 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: Accumulation Ratio (Rac) (MAD) [Срок оценки: Day 1 (pre-dose through 12 hours post-dose), Day 7 (pre-dose through 12 hours post-dose)]

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

South Korea · 1 центр

• Chungbuk National University Hospital — Cheongju-si

Идентификаторы

NCT: NCT07282145 · BCD101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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