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RecruitingAccepts healthy volunteersPhase 1

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

Dignify Therapeutics · with National Institute of Neurological Disorders and Stroke (NINDS) · NCT07882472

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
40
US sites recruiting
1
Study start
October 2026
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: DTI-117; Placebo

Conditions: Healthy Adult

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Thermo Fisher

    Austin, TX 78744

    Site contact: Katherine Sides, MD · 737-320-5556 · katherine.sides@trialmed.com

Study contacts (from the official record)

  • Ed Burgard, PhD · 919-371-8138 · eburgard@dignifytherapeutics.com
  • Karl Thor, PhD · 919-371-8138 · kthor@dignifytherapeutics.com
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in… (NCT07882472) | Bored Studies