Healthy VolunteersPhase 1NCT02603224
Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers
A Phase 1 study testing MRG-201 in people with Healthy Volunteers, run by miRagen Therapeutics, Inc. at 1 site in Canada.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the activity of a molecule called miR-29 that decreases the expression of collagen and other proteins that are involved in scar formation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MRG-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Apr 2017
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 18 and 45 years of age inclusive
- Body Mass Index (BMI) 18-35 kg/m^2 inclusive
- Must have 2 regions on the lower back/upper buttocks free of striae, scars, tattoos or other skin pathologies
- If engaged in sexual relations with a female of child-bearing potential, must be willing to use two effective contraceptive methods throughout the treatment period and for at least 12 weeks after the last treatment administration
Who cannot join
- Clinically significant abnormalities in medical history or physical exam which in the opinion of the Investigator would make the subject unsuitable for inclusion in the study
- History of cutaneous disorder that could interfere with the study or put the subject at risk
- History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening
- History of clinically significant anemia or evidence of clinically significant anemia at screening
- Positive for blood borne pathogen (HBV, HCV, HIV) at screening
- Prior malignancies within the past 3 years (allowing squamous cell and basal cell carcinomas that have been successfully treated)
- Use of systemic steroids or topical steroids on the target area within two months of the Baseline visit or use of topical steroids outside the target area within 14 days of the Baseline visit
- Use of an investigational small molecule drug within 28 days of the baseline visit or use of an investigational oligonucleotide or biologic drug within 90 days of the baseline visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of MRG-201 Following Local Intradermal Injection in Normal Healthy Volunteers
The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the activity of a molecule called miR-29 that decreases the expression of collagen and other proteins that are involved in scar formation. MRG-201 is being studied to determine if it can limit the formation of fibrous scar tissue in certain diseases.
MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a short skin incision. Volunteers may receive one or several doses of MRG-201, and will be monitored for local reactions in the skin, signs or symptoms of adverse effects on the body, and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to study how cells in the skin respond when exposed to MRG-201.
Read the detailed description
Study Design:
Cohorts of 3-6 healthy male volunteers, ages 18-45, will receive single or multiple ascending doses of MRG-201 by intradermal injection at one site and placebo at a second site over a period of up to 15 days, with follow-up for up to 28 days after the last dose to determine the maximum tolerated dose in intact or incised normal skin and the tendency for active drug to diffuse through the skin.
- Conditions
- Healthy Volunteers
- Being tested
- MRG-201, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG-201Drug
Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers.
PlaceboDrug
Intradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control.
| Study group | Role | What they receive |
|---|---|---|
| MRG-201 | Experimental | Not described Receives: Drug: MRG-201 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of MRG-201 based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
Measured: Up to 43 days
Secondary outcomes (2)
Area under the plasma concentration vs. time curve (AUC) of MRG-201 following single and repeat doses
Measured: Up to 17 days
Peak plasma concentration (Cmax) of MRG-201 following single and repeat doses
Measured: Up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- miRagen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilad S. Gordon, MD, Study director, miRagen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603224
- Sponsor's protocol ID
- MRG201-30-001
- Status last verified
- Jul 2017
- First submitted
- 9 Nov 2015
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of MRG-201 Following Local Intradermal Injection in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02603224
- Acronym / sponsor ID
- MRG201-30-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- miRagen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Nov 2015 (estimated)
- 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.
The primary objective of this study is to evaluate the safety and tolerability of the investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the activity of a molecule called miR-29 that decreases the expression of collagen and other proteins that are involved in scar formation. MRG-201 is being studied to determine if it can limit the formation of fibrous scar tissue in certain diseases.
MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a short skin incision. Volunteers may receive one or several doses of MRG-201, and will be monitored for local reactions in the skin, signs or symptoms of adverse effects on the body, and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to study how cells in the skin respond when exposed to MRG-201.
Detailed description
Study Design:
Cohorts of 3-6 healthy male volunteers, ages 18-45, will receive single or multiple ascending doses of MRG-201 by intradermal injection at one site and placebo at a second site over a period of up to 15 days, with follow-up for up to 28 days after the last dose to determine the maximum tolerated dose in intact or incised normal skin and the tendency for active drug to diffuse through the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRG-201 | Experimental | Drug: MRG-201 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males between 18 and 45 years of age inclusive
- Body Mass Index (BMI) 18-35 kg/m^2 inclusive
- Must have 2 regions on the lower back/upper buttocks free of striae, scars, tattoos or other skin pathologies
- If engaged in sexual relations with a female of child-bearing potential, must be willing to use two effective contraceptive methods throughout the treatment period and for at least 12 weeks after the last treatment administration
Key exclusion criteria (8 listed)
- Clinically significant abnormalities in medical history or physical exam which in the opinion of the Investigator would make the subject unsuitable for inclusion in the study
- History of cutaneous disorder that could interfere with the study or put the subject at risk
- History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening
- History of clinically significant anemia or evidence of clinically significant anemia at screening
- Positive for blood borne pathogen (HBV, HCV, HIV) at 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 |
|---|---|---|
| MRG-201Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers. | Drug | MRG-201 |
| PlaceboIntradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control. | Drug | Placebo |
Primary outcome
Safety and tolerability of MRG-201 based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
Time frame: Up to 43 days
2 secondary outcomes
Area under the plasma concentration vs. time curve (AUC) of MRG-201 following single and repeat doses
Time frame: Up to 17 days
Peak plasma concentration (Cmax) of MRG-201 following single and repeat doses
Time frame: Up to 17 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 6 Jul 2017.
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Screening Protocol
Pain
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.
Gilad S. Gordon, MD study director
miRagen Therapeutics, Inc.
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 MRG-201 in people with Healthy Volunteers, run by miRagen Therapeutics, Inc. at 1 site in Canada.
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 8 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 6 Jul 2017. 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 Canada. 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 and tolerability of MRG-201 based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events (time frame: Up to 43 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 6 Jul 2017.