Hypertrophic ScarPhase 1NCT03133130
Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
A Phase 1 study testing BMT101 in people with Hypertrophic Scar, run by Hugel at 1 site in South Korea.
Trial summary
Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers Read more about this study
- Who is it for?
- Ages 19 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- BMT101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2017to 14 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BMT101 in Healthy Male Volunteers
Read the 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
- Conditions
- Hypertrophic Scar
- Being tested
- BMT101, Placebo
- Keywords
- Scar, Scar prevention, siRNA
- Medical subject headings
- Cicatrix, Hypertrophic, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT101Drug
BMT101 is administered to 6 subjects in each of 4 groups.
PlaceboDrug
Placebo is administered to 2 subjects in each of 4 groups.
| Study group | Role | What they receive |
|---|---|---|
| BMT101 | Experimental | cp-lasiRNA Receives: Drug: BMT101 |
| Placebo | Placebo comparator | Normal Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (3)
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax
Determine peak whole blood concentration (Cmax)
Measured: 4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC
Determine area under the whole blood concentration versus time curve (AUC)
Measured: 4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½
Determine drug half-life in whole blood (T½)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start31 Jul 2017
- Primary completion14 Feb 2018
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133130
- Sponsor's protocol ID
- HG-BMT-PI-01
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03133130
- Acronym / sponsor ID
- HG-BMT-PI-01
- Conditions
- Hypertrophic Scar
- Keywords
- Scar, Scar prevention, siRNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMT101 | Experimental | Drug: BMT101cp-lasiRNA |
| Placebo | Placebo comparator | Drug: PlaceboNormal Saline |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Subjects with clinically significant medical or surgical history described below Clinically significant observations considered as unsuitable based on medical judgement by investigators
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMT101BMT101 is administered to 6 subjects in each of 4 groups. | Drug | BMT101 |
| PlaceboPlacebo is administered to 2 subjects in each of 4 groups. | Drug | Placebo |
Primary outcome
Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
Time frame: 14 days
Assess severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel
3 secondary outcomes
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: Cmax
Time frame: 4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: AUC
Time frame: 4 days
Pharmacokinetics (PK) of BMT101 by intradermal injection following single dose: T½
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMT101 in people with Hypertrophic Scar, run by Hugel at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation: Severity and frequency of reported adverse events, clinically-relevant changes in physical exams or laboratory testing assessed by medical personnel (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.