Safety and Pharmacokinetics Study of BCD101 in Healthy Vo... | NCT07282145

NCT07282145

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)	Cmax will be determined using non-compartmental analysis following a single ascending dose of BCD101. [Unit of Measure] ng/mL	Day 1 (pre-dose through 12 hours post-dose)
Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-t) (SAD)

Eligibility Module

Eligibility Criteria

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.

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases