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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult
• Intervention / Treatment: Drug: DTI-117; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ed Burgard, PhD; Phone Number: 919-371-8138; Email: eburgard@dignifytherapeutics.com
• Study Contact Backup: Name: Karl Thor, PhD; Phone Number: 919-371-8138; Email: kthor@dignifytherapeutics.com

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • Recruiting
      • Thermo Fisher
      • Contact: Katherine Sides, MD; Phone Number: 512-447-2985; Email: CRGstudyinfo.sm@thermofisher.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.03 mg/kg DTI-117; Participants receive a single IM dose of DTI-117 0.03 mg/kg.	Drug: DTI-117; Single intramuscular injection of DTI-117 at the assigned dose level.
Experimental: 0.05 mg/kg DTI-117; Participants receive a single IM dose of DTI-117 0.05 mg/kg.	Drug: DTI-117; Single intramuscular injection of DTI-117 at the assigned dose level.
Experimental: 0.1 mg/kg DTI-117; Participants receive a single IM dose of DTI-117 0.1 mg/kg.	Drug: DTI-117; Single intramuscular injection of DTI-117 at the assigned dose level.
Experimental: 0.2 mg/kg DTI-117; Participants receive a single IM dose of DTI-117 0.2 mg/kg.	Drug: DTI-117; Single intramuscular injection of DTI-117 at the assigned dose level.
Experimental: 0.3 mg/kg DTI-117; Participants receive a single IM dose of DTI-117 0.3 mg/kg.	Drug: DTI-117; Single intramuscular injection of DTI-117 at the assigned dose level.
Placebo Comparator: Placebo; Participants randomized to placebo within each cohort receive a single intramuscular injection of 0.9% Sodium Chloride Injection, USP.	Drug: Placebo; Single intramuscular injection of 0.9% Sodium Chloride Injection, USP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Absolute values and change from baseline	Up to seven days
Number of participants with abnormal lab test results	Absolute values and change from baseline for clinical chemistry and hematology	Up to seven days
Number of participants with abnormal vital signs	Absolute values and change from baseline (oral body temperature, respiratory rate, blood pressure, and heart rate)	Up to seven days
Number of participants with abnormal ECG	Absolute values and change from baseline ECG intervals	Up to seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Cmax	Maximum (peak) observed concentration of DTI-117	Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic Tmax	Time to maximum observed concentrations of DTI-117	Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic half-life (t1/2)	Time to terminal elimination half-life concentrations of DTI-117	Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic AUClast	Area under the concentration-time curve from zero to the last concentration quantifiable for DTI-117	Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic AUCinf	Area under the plasma concentration-time curve from time zero extrapolated to infinity for TI-117	Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic CL/F	Apparent total plasma clearance after oral administration of TI-117	Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Pharmacokinetic VzF	Apparent volume of distribution during terminal elimination phase after oral administration of DTI-117	Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose
Time to urination and defecation		24 hours post-dose

Collaborators and Investigators

• Sponsor: Dignify Therapeutics
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 13, 2026
• First Submitted That Met QC Criteria: October 13, 2026
• First Posted (Actual): October 20, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 5, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DTI-117-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No