A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Condition(s) studied
Investigational drug(s) / intervention(s)
DTI-117: Single intramuscular injection of DTI-117 at the assigned dose level.
Placebo: Single intramuscular injection of 0.9% Sodium Chloride Injection, USP.
Study 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.
Eligibility
Primary outcome measure(s)
- Number of participants with adverse events — Up to seven days
Absolute values and change from baseline - Number of participants with abnormal lab test results — Up to seven days
Absolute values and change from baseline for clinical chemistry and hematology - Number of participants with abnormal vital signs — Up to seven days
Absolute values and change from baseline (oral body temperature, respiratory rate, blood pressure, and heart rate) - Number of participants with abnormal ECG — Up to seven days
Absolute values and change from baseline ECG intervals
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Thermo Fisher | Austin | Texas | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07882472 on ClinicalTrials.gov ↗ ← All trials in the USA