Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers
ConditionEssential Hypertension
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorBichedam Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
* 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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BCD101 Low Dose Liquid Formulation
- BCD101 High Dose Liquid Formulation
- BCD101 Low + High Dose Liquid Formulation
- BCD101 Placebo Liquid Formulation
Treatment groups
56 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov