Hypertrophic Scar
Conditions
Keywords
Scar, Scar prevention, siRNA
Brief summary
Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
Detailed description
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
Interventions
DRUGBMT101
BMT101 is administered to 6 subjects in each of 4 groups.
DRUGPlacebo
Placebo is administered to 2 subjects in each of 4 groups.
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
19 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults, 19 \ 39 years of age 2. Body Mass Index (BMI) between 19 to 25kg/㎡ (19kg/㎡ ≤ BMI \< 25kg/㎡) and weight at least 50kg on the day of screening 3. Medically healthy with no clinically significant findings on vital signs during the screening period 4. Medically healthy with no clinically significant findings on physical examinations during the screening period
Exclusion criteria
1. 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 2. History of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, respiratory, musculoskeletal or any other conditions which can be problems for pharmacokinetic evaluation 3. Donated blood or blood components or had been transfused plasma within 60 days prior to the day of screening 4. Tobacco use within 30 days prior to the day of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel | 14 days | Assess severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax | 4 days | Determine peak whole blood concentration (Cmax) |
| Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC | 4 days | Determine area under the whole blood concentration versus time curve (AUC) |
| Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½ | 4 days | Determine drug half-life in whole blood (T½) |
Countries
South Korea
Outcome results
None listed