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

RecruitingPhase 1Healthy volunteers welcome

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.

Who can join

Ages 18 to 65 · All sexes · Healthy volunteers welcome

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Dignify Therapeutics · Participants: 40 · Started: Oct 28, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07882472

Locations in the U.S.

TexasThermo Fisher, Austin

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.