Healthy VolunteerPhase 1NCT03603431
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers
A Phase 1 study testing MRG-110 in people with Healthy Volunteer, run by miRagen Therapeutics, Inc. at 1 site in United States.
Trial summary
MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MRG-110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 13 Mar 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteers.
- Females must be of non-childbearing potential.
- If engaged in sexual relations with a female of child-bearing potential, males must be surgically sterile or must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
- Must have 2 regions on lower back/upper buttocks that are free of striae, scars, tattoos, or other skin pathologies.
- Must have no conditions that could increase risk of abnormal or delayed healing.
Who cannot join
- Clinically significant abnormalities in medical history or physical examination.
- Clinically significant abnormalities in laboratory tests at screening.
- History of cutaneous disorder.
- Hemangioma, history of hemangioblastoma, or other known vascular disorder.
- Positive for bloodborne pathogen (hepatitis B, hepatitis C, HIV).
- Use of an investigational drug or device within 28 days prior to Day 1, or use of an investigational biological or oligonucleotide drug within 90 days of Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of MRG-110 Following Local Intradermal Injection After Skin Excisional Wound Creation in Normal Healthy Volunteers
MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. The primary objective of this study is to investigate the safety and tolerability of MRG-110 when injected into the skin at the site of a small skin wound in normal healthy volunteers. Another objective is to study the pharmacokinetics of MRG-110 (the movement of a drug into, through and out of the body). Participants in the clinical trial will receive either a single dose or multiple doses of MRG-110 and/or placebo. Blood samples, urine samples and skin biopsies will be collected to measure how MRG-110 is processed by the body, and how the body responds when exposed to MRG-110.
- Conditions
- Healthy Volunteer
- Being tested
- MRG-110, Placebo
- Keywords
- Healthy Volunteers, MicroRNAs, Angiogenesis Inducing Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG-110Drug
Single ascending doses of MRG-110
PlaceboDrug
Single doses of placebo
MRG-110Drug
Multiple ascending doses of MRG-110
PlaceboDrug
Multiple doses of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose - MRG-110 | Experimental | Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites Receives: Drug: MRG-110; Drug: Placebo |
| Single Ascending Dose - Placebo | Placebo comparator | Intradermal injection of placebo at four wound sites Receives: Drug: Placebo |
| Multiple Ascending Dose - MRG-110 | Experimental | Intradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites Receives: Drug: MRG-110; Drug: Placebo |
| Multiple Ascending Dose - Placebo | Placebo comparator | Intradermal injection of placebo at four wound sites Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Measured: Up to Day 55
Secondary outcomes (2)
Area under the plasma concentration vs. time curve (AUC) of MRG-110 following single and repeat doses.
Measured: Up to Day 45
Peak plasma concentration (Cmax) of MRG-110 following single and repeat doses
Measured: Up to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start9 Apr 2018
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- miRagen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Escolar, MD, Study director, miRagen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603431
- Sponsor's protocol ID
- MRG110-01-001
- Status last verified
- May 2019
- First submitted
- 9 Jul 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Huang CK, Kafert-Kasting S, Thum T. Preclinical and Clinical Development of Noncoding RNA Therapeutics for Cardiovascular Disease. Circ Res. 2020 Feb 28;126(5):663-678. doi: 10.1161/CIRCRESAHA.119.315856. Epub 2020 Feb 27.
PubMed 32105576
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of MRG-110 Following Local Intradermal Injection After Skin Excisional Wound Creation in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03603431
- Acronym / sponsor ID
- MRG110-01-001
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteers, MicroRNAs, Angiogenesis Inducing Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- miRagen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 27 Jul 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.
MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area. The primary objective of this study is to investigate the safety and tolerability of MRG-110 when injected into the skin at the site of a small skin wound in normal healthy volunteers. Another objective is to study the pharmacokinetics of MRG-110 (the movement of a drug into, through and out of the body). Participants in the clinical trial will receive either a single dose or multiple doses of MRG-110 and/or placebo. Blood samples, urine samples and skin biopsies will be collected to measure how MRG-110 is processed by the body, and how the body responds when exposed to MRG-110.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose - MRG-110 | Experimental | Drug: MRG-110, Drug: PlaceboIntradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites |
| Single Ascending Dose - Placebo | Placebo comparator | Drug: PlaceboIntradermal injection of placebo at four wound sites |
| Multiple Ascending Dose - MRG-110 | Experimental | Drug: MRG-110, Drug: PlaceboIntradermal injection of MRG-110 at two wound sites and intradermal injection of placebo at two other wound sites |
| Multiple Ascending Dose - Placebo | Placebo comparator | Drug: PlaceboIntradermal injection of placebo at four wound sites |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Normal healthy volunteers.
- Females must be of non-childbearing potential.
- If engaged in sexual relations with a female of child-bearing potential, males must be surgically sterile or must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
- Must have 2 regions on lower back/upper buttocks that are free of striae, scars, tattoos, or other skin pathologies.
- Must have no conditions that could increase risk of abnormal or delayed healing.
Key exclusion criteria (6 listed)
- Clinically significant abnormalities in medical history or physical examination.
- Clinically significant abnormalities in laboratory tests at screening.
- History of cutaneous disorder.
- Hemangioma, history of hemangioblastoma, or other known vascular disorder.
- Positive for bloodborne pathogen (hepatitis B, hepatitis C, HIV).
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-110Single ascending doses of MRG-110 | Drug | Single Ascending Dose - MRG-110 |
| PlaceboSingle doses of placebo | Drug | Single Ascending Dose - MRG-110, Single Ascending Dose - Placebo |
| MRG-110Multiple ascending doses of MRG-110 | Drug | Multiple Ascending Dose - MRG-110 |
| PlaceboMultiple doses of Placebo | Drug | Multiple Ascending Dose - MRG-110, Multiple Ascending Dose - Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.
Time frame: Up to Day 55
2 secondary outcomes
Area under the plasma concentration vs. time curve (AUC) of MRG-110 following single and repeat doses.
Time frame: Up to Day 45
Peak plasma concentration (Cmax) of MRG-110 following single and repeat doses
Time frame: Up to Day 45
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 7 May 2019.
- Derived from this study: PubMed 32105576Huang CK, Kafert-Kasting S, Thum T. Preclinical and Clinical Development of Noncoding RNA Therapeutics for Cardiovascular Disease. Circ Res. 2020 Feb 28;126(5):663-678. doi: 10.1161/CIRCRESAHA.119.315856. Epub 2020 Feb 27.
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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.
Diana Escolar, 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-110 in people with Healthy Volunteer, run by miRagen Therapeutics, Inc. at 1 site in United States.
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 5 inclusion and 6 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 7 May 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 United States. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. (time frame: Up to Day 55). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03603431, which also lists 1 linked publication.
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 7 May 2019.