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

Phase 1

Completed

• Conditions: Hypertrophic Scar
• Interventions: Drug: Placebo; Drug: BMT101

• Registration Number: NCT03133130
• Lead Sponsor: Hugel

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

Study Timeline

• Study First Submitted: 2017-03-28
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Study Start: 2017-07-31
• Primary Completion: 2018-02-14
• Study Completion: 2018-02-14
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal Saline
BMT101	BMT101	cp-lasiRNA

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½	4 days	Determine drug half-life in whole blood (T½)
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: Cmax	4 days	Determine peak whole blood concentration (Cmax)

Trial Locations

Locations (1)

Hugel; 🇰🇷 Seoul, Korea, Republic of