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
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
Similar studies in Texas
All healthy volunteers studies in Texas →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study of LY4355756 in Healthy Participants
Eli Lilly and Company
- Location
- Dallas, TX
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
AstraZeneca
- Location
- San Antonio, TX + 1 other US site
- Eligibility basics
- Ages 18–80
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight
Eli Lilly and Company
- Location
- San Antonio, TX
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
Radiprodil in Participants With Hepatic Impairment
GRIN Therapeutics, Inc.
- Location
- DeSoto, TX + 1 other US site
- Eligibility basics
- Ages 18–75