Can a new drug tame inflammatory diseases by calming immune cells?
NCT ID NCT07745751
First seen Aug 04, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This early-stage trial is testing an investigational drug called TRT-448 in healthy adults to see if it is safe and well-tolerated. The drug works by modulating immune cells and could one day be used to treat inflammatory diseases. Participants receive either the drug or a placebo, and researchers monitor for side effects and how the drug behaves in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TRT-448, an investigational drug that modulates immune cells for the treatment of inflammatory disease
- What this could lead to
- If successful, this could pave the way for a new treatment option for inflammatory diseases by targeting immune cells.
- What could go wrong
- This is an early-phase trial focused on safety in healthy volunteers, so it may not work as intended or could have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Medically healthy , as determined by pre-study medical history, and without clinically significant abnormalities * Adult males and females, 18 to 55 years of age (inclusive) at screening * Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) with body weight: ≥ 70 kg for the SAD 1 cohort; ≥ 50 kg for all other cohorts * Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions Exclusion Criteria: * History of anaphylaxis or other significant allergy which would interfere with the volunteer's ability to participate in the study, including severe Types I-IV hypersensitivity reactions, cytokine release syndrome, or allergic reactions to multiple drugs * History or presence of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal cholecystectomy, irritable bowel syndrome, inflammatory bowel disease, etc.), esophageal, endocrine, immunologic, autoimmune and/or inflammatory disease, dermatologic, psychiatric, or neurological disease/disorder * History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study. * Any history of malignant disease in the last 10 years, including leukemia, lymphoma or any significant hematology/oncology disease. Note: Participants with curatively resected non-melanoma skin cancers \>2 years prior to screening or curatively excised cervical carcinoma in situ \> 5 years prior to screening are not excluded. * Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia. * History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death or screening QTcF \> 450 msec in males or \> 470 msec in female) or a known arrhythmia (Note: asymptomatic first-degree heart block is not exclusionary). * Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, gallbladder, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. * Liver function test results elevated more than 1.3-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). * Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73m2 using the 2021 CKD-EPI creatinine equation. * Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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