Actively Recruiting

Phase 1
Age: 19Years +
All Genders
Healthy Volunteers
NCT07282145

Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

Led by Bichedam Co., Ltd. · Updated on 2025-12-15

56

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

Who Can Participate

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults aged 19 years or older at screening
  • Body weight of at least 50.0 kg
  • Body mass index (BMI) between 18.0 and 30.0 kg/m²
  • No congenital or chronic medical conditions requiring treatment
  • Normal clinical laboratory tests, vital signs, physical exam, and 12-lead ECG at screening
  • Fully understood and voluntarily agreed to participate, providing written informed consent
Not Eligible

You will not qualify if you...

  • History or current significant liver, kidney, neurological, psychiatric, respiratory, endocrine, hematological, neoplastic, genitourinary, cardiovascular, gastrointestinal, or musculoskeletal disorders
  • Pregnant or breastfeeding females
  • History of severe allergic reactions to the investigational product or related medications
  • History of gastrointestinal diseases or surgeries affecting drug absorption (except simple appendectomy or hernia surgery)
  • Clinically significant ECG abnormalities at screening (QTc > 450 ms males, > 470 ms females; PR > 200 ms; QRS > 120 ms)
  • Significant laboratory abnormalities including liver function tests over twice normal or impaired kidney function (eGFR < 60 mL/min/1.73m²)
  • History of substance abuse or positive drug screening
  • Abnormal vital signs at screening (systolic ≤ 90 mmHg or ≥ 150 mmHg; diastolic ≤ 60 mmHg or ≥ 100 mmHg; pulse ≤ 40 bpm or ≥ 100 bpm)
  • Evidence of orthostatic hypotension
  • Use of enzyme-inducing or inhibiting drugs such as barbiturates within 1 month prior to first dosing
  • Abnormal diet or consumption of foods affecting drug handling
  • Use of medications or supplements affecting drug characteristics within specific time frames before dosing
  • Participation in another investigational drug trial within 6 months
  • Recent blood or platelet donation or transfusion within specified time frames
  • Excessive alcohol consumption or inability to abstain from alcohol during study
  • Smoking more than 10 cigarettes daily or inability to abstain from smoking during study
  • Recent consumption of grapefruit or caffeine-containing foods or inability to abstain
  • Engaging in strenuous exercise exceeding daily activity levels or inability to refrain
  • Planning pregnancy or unreliable contraception use during study
  • Any other investigator-determined reasons making participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea, 28644

Actively Recruiting

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Research Team

C

Chief Executive Officer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

14

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