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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-02-14

Brief Summary

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

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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

Conditions

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Hypertrophic Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BMT101

cp-lasiRNA

Group Type EXPERIMENTAL

BMT101

Intervention Type DRUG

BMT101 is administered to 6 subjects in each of 4 groups.

Placebo

Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is administered to 2 subjects in each of 4 groups.

Interventions

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BMT101

BMT101 is administered to 6 subjects in each of 4 groups.

Intervention Type DRUG

Placebo

Placebo is administered to 2 subjects in each of 4 groups.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes