Healthy AdultPhase 1NCT07882472
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
A Phase 1 study testing DTI-117 in people with Healthy Adult, run by Dignify Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- DTI-117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thermo Fisher
Austin, Texas, 78744
Katherine Sides, MD, 737-320-5556, katherine.sides@trialmed.com
About this study
Official title: 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.
- Conditions
- Healthy Adult
- Being tested
- DTI-117, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTI-117Drug
Single intramuscular injection of DTI-117 at the assigned dose level.
PlaceboDrug
Single intramuscular injection of 0.9% Sodium Chloride Injection, USP.
| Study group | Role | What they receive |
|---|---|---|
| 0.03 mg/kg DTI-117 | Experimental | Participants receive a single IM dose of DTI-117 0.03 mg/kg. Receives: Drug: DTI-117 |
| 0.05 mg/kg DTI-117 | Experimental | Participants receive a single IM dose of DTI-117 0.05 mg/kg. Receives: Drug: DTI-117 |
| 0.1 mg/kg DTI-117 | Experimental | Participants receive a single IM dose of DTI-117 0.1 mg/kg. Receives: Drug: DTI-117 |
| 0.2 mg/kg DTI-117 | Experimental | Participants receive a single IM dose of DTI-117 0.2 mg/kg. Receives: Drug: DTI-117 |
| 0.3 mg/kg DTI-117 | Experimental | Participants receive a single IM dose of DTI-117 0.3 mg/kg. Receives: Drug: DTI-117 |
| Placebo | Placebo comparator | Participants randomized to placebo within each cohort receive a single intramuscular injection of 0.9% Sodium Chloride Injection, USP. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Absolute values and change from baseline
Measured: Up to seven days
Number of participants with abnormal lab test results
Absolute values and change from baseline for clinical chemistry and hematology
Measured: 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)
Measured: Up to seven days
Number of participants with abnormal ECG
Absolute values and change from baseline ECG intervals
Measured: Up to seven days
Secondary outcomes (8)
Pharmacokinetic Cmax
Maximum (peak) observed concentration of DTI-117
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dignify Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882472
- Sponsor's protocol ID
- DTI-117-101
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07882472
- Acronym / sponsor ID
- DTI-117-101
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dignify TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.03 mg/kg DTI-117 | Experimental | Drug: DTI-117Participants receive a single IM dose of DTI-117 0.03 mg/kg. |
| 0.05 mg/kg DTI-117 | Experimental | Drug: DTI-117Participants receive a single IM dose of DTI-117 0.05 mg/kg. |
| 0.1 mg/kg DTI-117 | Experimental | Drug: DTI-117Participants receive a single IM dose of DTI-117 0.1 mg/kg. |
| 0.2 mg/kg DTI-117 | Experimental | Drug: DTI-117Participants receive a single IM dose of DTI-117 0.2 mg/kg. |
| 0.3 mg/kg DTI-117 | Experimental | Drug: DTI-117Participants receive a single IM dose of DTI-117 0.3 mg/kg. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to placebo within each cohort receive a single intramuscular injection of 0.9% Sodium Chloride Injection, USP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTI-117Single intramuscular injection of DTI-117 at the assigned dose level. | Drug | 0.03 mg/kg DTI-117, 0.05 mg/kg DTI-117, 0.1 mg/kg DTI-117, 0.2 mg/kg DTI-117, 0.3 mg/kg DTI-117 |
| PlaceboSingle intramuscular injection of 0.9% Sodium Chloride Injection, USP. | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Up to seven days
Absolute values and change from baseline
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
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)
Number of participants with abnormal ECG
Time frame: Up to seven days
Absolute values and change from baseline ECG intervals
8 secondary outcomes
Pharmacokinetic Cmax
Time frame: 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
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
Pharmacokinetic AUClast
Time frame: 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
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
Pharmacokinetic VzF
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DTI-117 in people with Healthy Adult, run by Dignify Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ed Burgard, PhD (919-371-8138, eburgard@dignifytherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Up to seven days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.