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

NCT03133130 | Completed Phase 1

• 1 other identifier: HG-BMT-PI-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertrophic Scar

Keywords

Scar; Scar prevention; siRNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax

  4 days

• Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC

  4 days

• Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½

  4 days

Study Arms (2)

BMT101

EXPERIMENTAL

cp-lasiRNA

Drug: BMT101

Placebo

PLACEBO COMPARATOR

Normal Saline

Drug: Placebo

Interventions

BMT101 DRUG

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

BMT101

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 19 Years - 39 Years
• Gender Eligibility Details: The clinical trial is comparative phase I study of the safety, tolerability, and pharmacokinetic characteristics of Investigational products, not to evaluate the efficacy of treatment. Therefore, other treatments or types are not considered and because this clinical trial has experimental aspects that are not verified, this clinical trial is conducted for healthy male volunteers.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugel: lead

Study Sites (1)

Hugel

Seoul, 06162, South Korea

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 28, 2017
• Study Start: July 31, 2017
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: April 25, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)