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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

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.
BCD101 High Dose Liquid Formulation
Drug
\[SAD\] 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.
BCD101 Low + High Dose Liquid Formulation
Drug
\[MAD\] A combination of low-dose and high-dose BCD101 liquid formulations, administered orally as separate sachets simultaneously. Used for multiple dosing.
BCD101 Placebo Liquid Formulation
Drug
\[SAD Placebo\] 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.

Treatment groups

56 Participants

are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: SAD-1(Treatment group)Experimental treatment 1 intervention

Group B: SAD-2(Treatment group)Experimental treatment 1 intervention

Group C: SAD-3(Treatment group)Experimental treatment 1 intervention

Group D: SAD-4(Treatment group)Experimental treatment 1 intervention

Group E: MAD-1(Treatment group)Experimental treatment 1 intervention

Group F: MAD-2(Treatment group)Experimental treatment 1 intervention

Group G: MAD-3(Treatment group)Experimental treatment 1 intervention

Group H: SAD-1(Placebo group)Experimental treatment 1 intervention

Group I: SAD-2(Placebo group)Experimental treatment 1 intervention

Group J: SAD-3(Placebo group)Experimental treatment 1 intervention

Group K: SAD-4(Placebo group)Experimental treatment 1 intervention

Group L: MAD-1(Placebo group)Experimental treatment 1 intervention

Group M: MAD-2(Placebo group)Experimental treatment 1 intervention

Group N: MAD-3(Placebo group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame

Day -1, Day 1, post-study visit (Day 4-7)

2

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

Time frame

Screening, Day -1, Day 1, post-study visit (Day 4-7)

3

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

Time frame

Screening, Day -1, Day 1, post-study visit (Day 4-7)

4

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)

Time frame

Screening, Day -1, Day 1, post-study visit (Day 4-7)

Secondary outcomes

1

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

Time frame

Day 1 (pre-dose through 12 hours post-dose)

2

Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-t) (SAD)

AUC₀-t will be calculated using non-compartmental analysis following a single ascending dose of BCD101. \[Unit of Measure\] ng·h/mL

Time frame

Day 1 (pre-dose through 12 hours post-dose)

3

Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)

AUCinf will be calculated from the concentration-time curve following a single ascending dose of BCD101. \[Unit of Measure\] ng·h/mL

Time frame

Day 1 (pre-dose through 12 hours post-dose)

4

Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)

Tmax will be derived from the plasma concentration-time profile following a single ascending dose of BCD101. \[Unit of Measure\] Hour (h)

Time frame

Day 1 (pre-dose through 12 hours post-dose)

Safety and Pharmacokinetics Study of BCD101 in Healthy Volunteers

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts