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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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • DT-216P2

    Drug

    DT-216P2 will be administered as subcutaneous injection, subcutaneous infusion and intravenous infusion.

  • Saline

    Drug

    Normal saline solution will be used as placebo control.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: DT-216P2Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of treatment emergent adverse events (TEAEs)

To evaluate the safety and tolerability of single ascending doses of DT-216P2 in normal healthy participants by frequency of treatment-emergent adverse events (TEAEs).

Time frame
From first dose to end of study, Day 30 post first dose administration.

Secondary outcomes

1

Maximum Plasma Concentration (Cmax) of DT-216P2

Time frame
Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
2

Time to Maximum Plasma Concentration (Tmax) of DT-216P2

Time frame
Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
3

Area Under the Concentration-time Curve (AUC) of DT-216P2

Time frame
Pre-dose and up to 240 hours post first dose for both SC and IV infusion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Design Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: