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RECRUITING
NCT07882472
PHASE1

A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.

Sponsor: Dignify Therapeutics

View on ClinicalTrials.gov

Summary

This is a single ascending dose, double-blind, placebo-controlled, randomized evaluation of the safety, tolerability, and pharmacokinetics of DTI-117 in healthy volunteers. There will be up to five cohorts of 8 healthy participants each cohort.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Intramuscular (IM) Doses of DTI-117 in Healthy Participants.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10

Completion Date

2027-04

Last Updated

2026-10-26

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

DTI-117

Single intramuscular injection of DTI-117 at the assigned dose level.

DRUG

Placebo

Single intramuscular injection of 0.9% Sodium Chloride Injection, USP.

Locations (1)

Thermo Fisher

Austin, Texas, United States