NCT06772870

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

A Phase 1, Double-Masked, Randomized, Placebo-Controlled, Single Ascending Dose Crossover Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous DT-216P2 in Normal Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Design Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2025-01-14
• Last updated: 2025-02-21

Locations

1 site across 1 country: Australia