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