Determine Range of Tissue Frataxin Concentrations and Other Potential Biomarkers

Larimar Therapeutics

Status

Completed

Conditions

Healthy Volunteers

Friedreich Ataxia

Treatments

Diagnostic Test: Buccal Swabs, Blood Draws and Skin Punch Biopsy

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05028764

CLIN-1601-002

Details and patient eligibility

About

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).

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is a healthy male or female,18-50 years of age
Subject has a body mass index (BMI) ≥18.0 and ≤32.0 as of the screening visit.
Subject is racially Caucasian, Asian, Native Hawaiian, or Native American.

Exclusion criteria

Subject used erythropoietin, etravirine, or gamma interferon within 3 months prior to the Day 1 (assessment) visit.
Subject has a chronic condition that requires ongoing prescription drug treatment.
Subject use of any statin medications within 3 months before the Day 1 (assessment) visit.
Subject use of any lipid-lowering agents, other than statins, within 6 weeks before the Day 1 (assessments) visit.
Subject is racially black or African American.
Pregnant or breast-feeding female subjects.
Subject has a known history of drug or alcohol abuse or current suspected drug or alcohol abuse.
Subject is positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis A virus (HAV).
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.