Healthy Volunteers Clinical Trial
Official title:
A Study to Determine the Range of Tissue Frataxin Concentrations and Other Potential Biomarkers for Friedreich's Ataxia in Normal Healthy Volunteers
| Verified date | February 2022 |
| Source | Larimar Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To examine range of tissue frataxin (FXN) concentrations, specific ribonucleic acids, other proteins and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without Friedreich's ataxia (FRDA).
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | February 4, 2022 |
| Est. primary completion date | February 4, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | Inclusion Criteria: 1. Subject is a healthy male or female,18-50 years of age 2. Subject has a body mass index (BMI) =18.0 and =32.0 as of the screening visit. 3. Subject is racially Caucasian, Asian, Native Hawaiian, or Native American. Exclusion Criteria: 1. Subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to the Day 1 (assessment) visit. 2. Subject has a chronic condition that requires ongoing prescription drug treatment. 3. Subject use of any statin medications within 3 months before the Day 1 (assessment) visit. 4. Subject use of any lipid-lowering agents, other than statins, within 6 weeks before the Day 1 (assessments) visit. 5. Subject is racially black or African American. 6. Pregnant or breast-feeding female subjects. 7. Subject has a known history of drug or alcohol abuse or current suspected drug or alcohol abuse. 8. Subject is positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis A virus (HAV). 9. Subject has any condition, disease, or situation, that in the opinion of the principal investigator (PI), could confound the results of the study or put the subject at undue risk, making participation inadvisable. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinilabs Drug Development Corporation | Eatontown | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Larimar Therapeutics, Inc. | Clinilabs, Inc. |
United States,
Deutsch EC, Santani AB, Perlman SL, Farmer JM, Stolle CA, Marusich MF, Lynch DR. A rapid, noninvasive immunoassay for frataxin: utility in assessment of Friedreich ataxia. Mol Genet Metab. 2010 Oct-Nov;101(2-3):238-45. doi: 10.1016/j.ymgme.2010.07.001. Epub 2010 Jul 8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Examine tissue frataxin concentrations in buccal cells, blood and skin cells | Range of tissue frataxin levels in buccal cells, blood and skin cells | 1 day | |
| Secondary | Examine specific ribonucleic acids (RNAs), other proteins, and specialized lipids in buccal cells and blood | Range of specific ribonucleic acids (RNAs), other proteins, and specialized lipids in buccal cells and blood | 1 day |
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