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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertrophic Scar
• Intervention / Treatment: Drug: BMT101; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06162
    • Hugel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Normal Saline	Drug: Placebo; Placebo is administered to 2 subjects in each of 4 groups.
EXPERIMENTAL: BMT101; cp-lasiRNA	Drug: BMT101; BMT101 is administered to 6 subjects in each of 4 groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax	Determine peak whole blood concentration (Cmax)	4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC	Determine area under the whole blood concentration versus time curve (AUC)	4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½	Determine drug half-life in whole blood (T½)	4 days

Collaborators and Investigators

• Sponsor: Hugel

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2017
• Primary Completion (ACTUAL): February 14, 2018
• Study Completion (ACTUAL): February 14, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Scar; siRNA; Scar prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Cicatrix, Hypertrophic
• Other Study ID Numbers: HG-BMT-PI-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No