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

November 5, 2026 updated by: Dignify Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Up to seven days

Absolute values and change from baseline
Up to seven days
Number of participants with abnormal lab test results
Time Frame: Up to seven days

Absolute values and change from baseline for clinical chemistry and hematology
Up to seven days
Number of participants with abnormal vital signs
Time Frame: Up to seven days

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
Time Frame: Up to seven days

Absolute values and change from baseline ECG intervals
Up to seven days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Cmax
Time Frame: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

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 Frame: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

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 Frame: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

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
Time Frame: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

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
Time Frame: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

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
Time Frame: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

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
Time Frame: Pre-dose and at 1, 2, 5, 10, 20, 40, and 60 minutes and 2 and 6 hours post-dose

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
Time Frame: 24 hours post-dose
24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dignify Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings