A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants
ConditionFriedreich Ataxia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDesign Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DT-216P2
- Saline
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov