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

Hugel

Status and phase: Completed; Phase 1

Conditions: Hypertrophic Scar

Treatments: Drug: Placebo; Drug: BMT101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03133130

HG-BMT-PI-01

Details and patient eligibility

About

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

Full 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

Enrollment: 32 patients

Sex: Male

Ages: 19 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups, including a placebo group

BMT101

Experimental group

Description:

cp-lasiRNA

Treatment:

Drug: BMT101

Placebo

Placebo Comparator group

Description:

Normal Saline

Treatment:

Drug: Placebo