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Recruiting Phase 1

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

NCT07882472 · tracked via the Priya Life Science USA tracker
Sponsor
Dignify Therapeutics
Phase
Phase 1
Started
2026-10
Last updated
2026-10-26

Condition(s) studied

Healthy Adult

Investigational drug(s) / intervention(s)

DTI-117Placebo

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Provide written informed consent to participate. * Adult male and female healthy volunteers between 18 to 65 years of age, inclusive. * General good health, with no clinically relevant abnormalities as determined by the medical history, physical exam, ECG, and clinical laboratory results. * Screening body weight between 45 and 100 kg, inclusive, with body mass index (BMI) ≤32 kg/m2. Exclusion Criteria: * Gastrointestinal or urological surgery in the previous 6 months. * Presence of any clinically significant infectious, cardiac, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, in the opinion of the investigator. * History of colitis. * Current chronic intermittent constipation requiring medication more than twice per month. * Use of any investigational drug within 30 days of Screening or 5 drug half-lives, whichever is longer. * Individuals not willing or unable to tolerate blood draws or individuals with poor venous access. * Presence or history of any condition that, in the opinion of the Investigator, might reasonably jeopardize the safety of the participant, the ability to collect study data, or the validity of the study results.

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)

FacilityCityRegionStatus
Thermo Fisher Austin Texas Recruiting
Official registry record

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