search
Back to results

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

Primary Purpose

Hypertrophic Scar

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BMT101
Placebo
Sponsored by
Hugel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar focused on measuring Scar, Scar prevention, siRNA

Eligibility Criteria

19 Years - 39 Years (Adult)MaleAccepts 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

Sites / Locations

  • Hugel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BMT101

Placebo

Arm Description

cp-lasiRNA

Normal Saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2017
Last Updated
April 24, 2018
Sponsor
Hugel
search

1. Study Identification

Unique Protocol Identification Number
NCT03133130
Brief Title
Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
Official Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
February 14, 2018 (Actual)
Study Completion Date
February 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
Keywords
Scar, Scar prevention, siRNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMT101
Arm Type
Experimental
Arm Description
cp-lasiRNA
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline
Intervention Type
Drug
Intervention Name(s)
BMT101
Intervention Description
BMT101 is administered to 6 subjects in each of 4 groups.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is administered to 2 subjects in each of 4 groups.
Primary Outcome Measure Information:
Title
Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
Description
Assess severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax
Description
Determine peak whole blood concentration (Cmax)
Time Frame
4 days
Title
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC
Description
Determine area under the whole blood concentration versus time curve (AUC)
Time Frame
4 days
Title
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½
Description
Determine drug half-life in whole blood (T½)
Time Frame
4 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Hugel
City
Seoul
ZIP/Postal Code
06162
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs