Determine Range of Tissue Frataxin Concentrations and Other Potential Biomarkers

Larimar Therapeutics, Inc.60 enrolled

Overview

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).

Primary Objective: To examine the range of tissue frataxin (FXN) concentrations in the buccal cells, blood, and skin cells of normal healthy volunteers without FRDA. Secondary Objective: To examine the range of specific ribonucleic acids (RNAs), other proteins, and specialized lipids in the buccal cells, blood, and skin cells of normal healthy volunteers without FRDA.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Friedreich Ataxia Healthy Volunteers

Interventions

Buccal Swabs, Blood Draws and Skin Punch BiopsyDIAGNOSTIC_TEST

Buccal Swabs - FXN and specific RNA markers; Blood Draws - Lipid panel, Protein Marker Analysis and Gene RNA Analysis; Skin Punch Biopsy - Protein Markers

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinilabs Drug Development Corporation

Eatontown, New Jersey, United States

Outcomes

Primary Outcomes

Examine tissue frataxin concentrations in buccal cells, blood and skin cells

Range of tissue frataxin levels in buccal cells, blood and skin cells

Time frame: 1 day

Secondary Outcomes

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

Time frame: 1 day

Data from ClinicalTrials.gov

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