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Tests treatment safety and results for Essential Hypertension
Official title Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers
ClinicalTrials.gov ID: NCT07282145
What this study is testing
What is BCD101 Low Dose Liquid Formulation?
BCD101 Low Dose Liquid Formulation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for essential hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- Fully understood the detailed explanation of this clinical trial, voluntarily agreed to participate, and provided written informed consent agreeing...
You likely can't join if
- History or current clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematological, neoplastic, genitourinary...
- Female people 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...
- History of gastrointestinal diseases or surgeries that could affect absorption of the investigational drug (e.g., Crohn's disease, ulcers, acute or...
- Clinically significant abnormalities on 12-lead ECG at screening, including:
- QTc interval \> 450 ms (males) or \> 470 ms (females)
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- History or current clinically significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematological, neoplastic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal disorders.
- Female people 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...
- 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...
- 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...
- 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...
- 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...
- Any other reasons deemed by the investigator to make the subject unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Cheongju-si, North Chungcheong, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cheongju-si, North Chungcheong, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.