A Multiple Ascending Dose Study of DT-216P2 in Patients With Friedreich's Ataxia

Inclusion Criteria:

• Participants must be 18-65 years of age inclusive, at the time of signing theinformed consent.

• Genetically confirmed diagnosis of FA, with homozygous GAA repeat expansions in thefrataxin gene.

• Stage 5.5 or less on the FSA at screening.

• BMI between 16 and 32 kg/m2 at screening; weight should be <= 100 kg at screening.

• Male and/or female using protocol defined and regulatory approved contraception.

• Capable of giving signed informed consent.

Exclusion Criteria:

• Any concomitant medical condition that in the opinion of the investigator, puts theparticipant at risk or precludes participant from completing the study protocol.

• Any clinically significant nonmedical conditions and psychiatric disorders thatcould put the participant at higher risk for participation in the study, influencethe participant's ability to participate in the study, or interfere withinterpretation of the participant's study results, in the opinion of theinvestigator.

• Received an investigational agent within the last 30 days or 5 half-lives, whicheverlonger, prior to the first dose of study drug, or are in follow-up of anotherclinical study prior to study enrollment. Exception: Potential participants who arecurrently on Omaveloxolone must be on stable doses for at least 3 months.

• Is not willing to comply with the contraceptive requirements during the studyperiod, as per protocol.