← Back to all trials
Recruiting
NCT07882472
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Conditions: Healthy Adult
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: Dignify Therapeutics
Location: Thermo Fisher Austin Texas
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 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.
Source: ClinicalTrials.gov (NCT07882472). StuddyBuddy aggregates publicly available trial information.