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A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Sponsor: Dignify Therapeutics
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
DTI-117
Single intramuscular injection of DTI-117 at the assigned dose level.
Placebo
Single intramuscular injection of 0.9% Sodium Chloride Injection, USP.
Locations (1)
Thermo Fisher
Austin, Texas, United States