Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
miRagen Therapeutics, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must provide written informed consent.
Females must not be pregnant, or lactating, and have negative pregnancy tests.
Study candidates should be likely to form keloids in the upper back/shoulder area after punch biopsy based on a history of a high frequency of keloid formation (≥ 10 keloids) or a history of large keloids (≥ 4 cm).
Subjects should not anticipate requiring systemic corticosteroids during the study.
Must have area in upper back/shoulder region free of keloids, acne, striae, or other skin pathologies or complications.
Female subjects of childbearing potential or male subjects engaged in sexual relations with a female of childbearing potential 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.
You may not be if
Clinically significant abnormalities in medical history or physical exam that, in the opinion of the Investigator, would make the subject unsuitable for inclusion in the study.
History of genetic disorders that predispose to keloids (e.g. Ehlers-Danlos syndrome, Ullrich congenital muscular dystrophy, etc.).
History of renal or liver dysfunction or evidence of renal or liver dysfunction at screening.
Evidence of clinically significant anemia, neutropenia, or thrombocytopenia at screening.
History of bleeding diathesis or coagulopathy.
Active or uncontrolled infection at screening or baseline.
Recent history of alcoholism, drug abuse or illicit drugs (within the last year), and agreement to refrain from using illicit drugs throughout the study.
Positive for bloodborne 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 within 4 weeks of the Baseline visit or local use of steroids within 1 week of the Baseline visit.
Use of an investigational small molecule drug within 30 days of the baseline visit or use of an investigational oligonucleotide or biologic drug within 90 days of the baseline visit.
Clareo Health | Efficacy, Safety, and Tolerability of Remlarsen (MRG-201) Following Intradermal Injection in Subjects With a History of Keloids
