A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants

Design Therapeutics

Status and phase

Not yet enrolling

Phase 1

Conditions

Friedreich Ataxia

Treatments

Drug: DT-216P2

Drug: Saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT06772870

DTX-216P2-011

Details and patient eligibility

About

This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants must be 18-45 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
Agree to abstain from strenuous physical activity outside of daily norm, until end of study.
Body mass index between 16 and 32 kg/m2 (inclusive) 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 the participant at risk or precludes participant from completing the study protocol.
Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
Is not willing to comply with the contraceptive requirements during the study period, as per protocol.