DTI-117 for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effects of a new treatment called DTI-117 in healthy volunteers. Participants will receive a single dose of either DTI-117 or a placebo (a harmless substance resembling the treatment) to assess how their bodies handle it. Suitable participants should be generally healthy adults without recent major surgeries or ongoing serious health issues. The trial aims to understand how different doses of DTI-117 are tolerated and processed in the body. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.
Is there any evidence suggesting that DTI-117 is likely to be safe for humans?
Research has shown that DTI-117 remains in the early stages of human safety testing. Clear data from previous studies about its safety is not yet available. This first phase of testing focuses on assessing how well people tolerate DTI-117. Researchers closely monitor treatments in early trials to identify any side effects. If DTI-117 receives approval for other uses, it might suggest some level of safety, but this is not always guaranteed. More information is needed to fully understand the safety of DTI-117. Participants in this trial will contribute valuable information.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about DTI-117 because it represents a novel approach to treatment with its specific dosages and delivery method. Unlike many standard treatments that require multiple doses over time, DTI-117 is administered as a single intramuscular injection, which could simplify treatment regimens and improve patient compliance. Additionally, its unique dosing strategy, ranging from 0.03 mg/kg to 0.3 mg/kg, allows for personalized treatment, potentially enhancing efficacy and minimizing side effects. This innovative approach holds promise for offering a quicker and more efficient solution compared to traditional options.
What evidence suggests that DTI-117 could be effective?
Existing clinical data does not yet include research on the effectiveness of DTI-117. As a new treatment, the focus remains on understanding its function. Researchers believe DTI-117 affects certain biological pathways that could help treat specific conditions. Early studies in the lab and with animals have shown promise, but further research is necessary to determine its effectiveness in humans. This trial will test various dosages of DTI-117 to understand how the body processes the drug and to ensure its safety. Additional data is required to confirm its effectiveness.678910
Are You a Good Fit for This Trial?
This trial is for healthy adults who do not have any significant medical conditions. Participants must meet health requirements set by the study and cannot join if they have issues that could affect safety or results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intramuscular dose of DTI-117 or placebo
Follow-up
Participants are monitored for safety and pharmacokinetics, including adverse events and lab tests
What Are the Treatments Tested in This Trial?
Interventions
- DTI-117
Trial Overview
The study tests different single doses of a new drug called DTI-117, given as an injection into the muscle, compared to a placebo. It aims to see how safe and tolerable DTI-117 is in healthy people.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Participants receive a single IM dose of DTI-117 0.3 mg/kg.
Participants receive a single IM dose of DTI-117 0.2 mg/kg.
Participants receive a single IM dose of DTI-117 0.1 mg/kg.
Participants receive a single IM dose of DTI-117 0.05 mg/kg.
Participants receive a single IM dose of DTI-117 0.03 mg/kg.
Participants randomized to placebo within each cohort receive a single intramuscular injection of 0.9% Sodium Chloride Injection, USP.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dignify Therapeutics
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Citations
17 U.S. Code § 117 - Limitations on exclusive rights
Under section 117, an action for infringement of a copyrighted work by means of a computer would necessarily be a federal action brought under the new title 17.
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