Single-dose study of DTI-117 given by injection in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, double-blind, placebo-controlled study will use up to five groups of eight healthy adults to evaluate the safety, tolerability, and pharmacokinetics of intramuscular DTI-117 after a single ascending dose. Participants will receive either DTI-117 or placebo and will be monitored for adverse events, vital signs, ECGs, and laboratory measurements. The trial aims to identify a safe dose range and understand how the drug behaves in the body. Enrollment targets healthy volunteers aged 18 to 65 with specific weight and health criteria, excluding those with recent surgeries or significant medical conditions. The study is sponsored by Dignify Therapeutics with collaboration from NINDS and conducted at Thermo Fisher in Austin, Texas.

Why it matters

Who can join: the full rules

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.

Where it's running

• Thermo Fisher
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: Ed Burgard, PhD
• Email: eburgard@dignifytherapeutics.com
• Phone: 919-371-8138

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.