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

NCT06772870 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-02-21

No results posted yet for this study

Summary

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.

Conditions

  • Friedreich Ataxia

Interventions

DRUG

DT-216P2

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

DRUG

Saline

Normal saline solution will be used as placebo control.

Sponsors & Collaborators

  • Design Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ofer Gronen, MD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772870 on ClinicalTrials.gov