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Can a new drug tame inflammatory diseases by calming immune cells?

NCT ID NCT07745751

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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