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

Hypertrophic Scar Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133130
• Other study ID #: HG-BMT-PI-01
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2017
• Last updated: April 24, 2018
• Start date: July 31, 2017
• Est. completion date: February 14, 2018

Study information

• Verified date: April 2017
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 14, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Drug:
• BMT101
BMT101 is administered to 6 subjects in each of 4 groups.
• Placebo
Placebo is administered to 2 subjects in each of 4 groups.

Locations

Country	Name	City	State
Korea, Republic of	Hugel	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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