Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers

Study Overview
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Brief Summary
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Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers

Detailed Description
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A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy Male Volunteers

Official Title
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A Randomized, Single Blind, Single Dose, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intradermal Dosage Form of BMT101 in Healthy Male Volunteers

Conditions
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Hypertrophic Scar

Intervention / Treatment
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* Drug: BMT101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, 19   39 years of age Body Mass Index (BMI) between 19 to 25kg/㎡ (19kg/㎡ ≤ BMI < 25kg/㎡) and weight at least 50kg on the day of screening Medically healthy with no clinically significant findings on vital signs during the screening period Medically healthy with no clinically significant findings on physical examinations during the screening period Exclusion Criteria: Subjects with clinically significant medical or surgical history described below Clinically significant observations considered as unsuitable based on medical judgement by investigators Skin disorder (psoriasis or contact dermatitis) which may affect absorption of the investigational product, or scar, skin abnormality, history of surgery (excluding simple appendectomy or herniorrhaphy) which can interrupt intradermal injections History of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, respiratory, musculoskeletal or any other conditions which can be problems for pharmacokinetic evaluation Donated blood or blood components or had been transfused plasma within 60 days prior to the day of screening Tobacco use within 30 days prior to the day of screening

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMT101<br>cp-lasiRNA | Drug: BMT101<br>* BMT101 is administered to 6 subjects in each of 4 groups.<br>|
| Placebo Comparator: Placebo<br>Normal Saline | Drug: Placebo<br>* Placebo is administered to 2 subjects in each of 4 groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel | Assess severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax | Determine peak whole blood concentration (Cmax) | 4 days | 
| Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC | Determine area under the whole blood concentration versus time curve (AUC) | 4 days | 
| Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½ | Determine drug half-life in whole blood (T½) | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scar prevention, Scar, siRNA