HealthyPhase 1NCT03547141
Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers
A Phase 1 study testing MBA-P01 and BOTOX in people with Healthy, run by Medy-Tox at 1 site in South Korea.
Trial summary
To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MBA-P01 and BOTOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Apr 2018to 1 Nov 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male adults aged between 20 and 45 years
Who cannot join
- Subjects not appropriate for participating in this study according to the investigator's opinion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea, St. Paul's Hospital
Seoul
About this study
Official title: A Randomized, Double-blind, Active-controlled, Single-center, Phase 1 Study to Determine the Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers
To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers
- Conditions
- Healthy
- Being tested
- MBA-P01, BOTOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBA-P01Drug
injection of MBA-P01 into the muscle of each contralateral foot in equal doses
BOTOXDrug
injection of BOTOX into the muscle of each contralateral foot in equal doses
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin 1U | Experimental | Not described Receives: Drug: MBA-P01; Drug: BOTOX |
| botulinum toxin 5U | Experimental | Not described Receives: Drug: MBA-P01; Drug: BOTOX |
| botulinum toxin 15U | Experimental | Not described Receives: Drug: MBA-P01; Drug: BOTOX |
| botulinum toxin 30U | Experimental | Not described Receives: Drug: MBA-P01; Drug: BOTOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
to estimate the pharmacodynamic aspects of muscle
percentage of reduction of CMAP amplitude of the muscle from baseline
Measured: day 3, 14, week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start16 Apr 2018
- Primary completion28 Aug 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myungeun Chung, Principal investigator, The Catholic University, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547141
- Sponsor's protocol ID
- MT14-KR18EDB102
- Status last verified
- Mar 2019
- First submitted
- 29 Apr 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Single-center, Phase 1 Study to Determine the Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03547141
- Acronym / sponsor ID
- MT14-KR18EDB102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 6 Jun 2018 (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.
To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin 1U | Experimental | Drug: MBA-P01, Drug: BOTOX |
| botulinum toxin 5U | Experimental | Drug: MBA-P01, Drug: BOTOX |
| botulinum toxin 15U | Experimental | Drug: MBA-P01, Drug: BOTOX |
| botulinum toxin 30U | Experimental | Drug: MBA-P01, Drug: BOTOX |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male adults aged between 20 and 45 years
Key exclusion criteria (1 listed)
- Subjects not appropriate for participating in this study according to the investigator's opinion
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 |
|---|---|---|
| MBA-P01injection of MBA-P01 into the muscle of each contralateral foot in equal doses | Drug | botulinum toxin 15U, botulinum toxin 1U, botulinum toxin 30U, botulinum toxin 5U |
| BOTOXinjection of BOTOX into the muscle of each contralateral foot in equal doses | Drug | botulinum toxin 15U, botulinum toxin 1U, botulinum toxin 30U, botulinum toxin 5U |
Primary outcome
to estimate the pharmacodynamic aspects of muscle
Time frame: day 3, 14, week 4, 8, 12
percentage of reduction of CMAP amplitude of the muscle from baseline
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 26 Mar 2019.
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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.
Myungeun Chung principal investigator
The Catholic University, St. Paul's Hospital
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 MBA-P01 and BOTOX in people with Healthy, run by Medy-Tox 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 1 inclusion and 1 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 26 Mar 2019. 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. 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?
to estimate the pharmacodynamic aspects of muscle (time frame: day 3, 14, week 4, 8, 12). 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 26 Mar 2019.