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.

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.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * 1\. Provide written informed consent to participate. 2. Adult male and female healthy volunteers between 18 to 65 years of age, inclusive. 3\. General good health, with no clinically relevant abnormalities as determined by the medical history, physical exam, ECG, and clinical laboratory results. 4\. Screening body weight between 45 and 100 kg, inclusive, with body mass index (BMI) ≤32 kg/m2. Exclusion Criteria: * 1\. Gastrointestinal or urological surgery in the previous 6 months. 2. Presence of any clinically significant infectious, cardiac, pulmonary, hepatic,…

Interventions

Drug
DTI-117
DTI-117 or matching placebo

Location

Thermo Fisher
Austin, Texas

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.

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions