Can a pill that degrades IRAK4 tame autoimmune inflammation?
NCT ID NCT06082323
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
Researchers are testing LT-002-158, an oral drug that degrades IRAK4, a protein involved in inflammation. This first-in-human trial gives the drug to healthy volunteers to check its safety, tolerability, and how the body processes it. The study also looks at how food affects drug absorption. If successful, LT-002-158 could be developed as a treatment for autoimmune and inflammatory diseases like hidradenitis suppurativa and atopic dermatitis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LT-002-158, an oral IRAK4 protein degrader
- What this could lead to
- If safe and effective, LT-002-158 could become a new oral treatment for autoimmune and inflammatory conditions like hidradenitis suppurativa and atopic dermatitis.
- What could go wrong
- This is an early phase 1 trial in healthy volunteers, so it does not yet test effectiveness. The drug may fail safety checks or not work as hoped in later trials.
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
-
150 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
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Nov 2025
- 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
-
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: * 1\) Healthy volunteers who fully understand the content, process, and possible adverse event of the study and capable of giving written informed consent form. 2\) Male or female between 18 and 55 years of age (inclusive), at the time of signing the informed consent form. 3\) Body mass index (BMI) range within 18\~30 kg/m2 (inclusive), and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female. 4\) Healthy volunteers who must be confirmed as negative in the SARS-CoV-2 test on Day -2 (admission). 5\) Healthy volunteers with no significant medical history judged by the Investigator and in good health, fully physical examinations, vital signs, 12-lead electrocardiograms (12-ECGs), clinical laboratory tests (hematology, urinalysis, blood chemistry and coagulation test), serum virology test. 6\) Females must be non- pregnant, non- lactating and must have negative serum pregnancy test at screening. Women of child bearing potential and males must be willing to use highly effective acceptable forms of contraception from screening to 6 months after the last study drug administration. Males and females must be willing to avoid donating sperm or egg respectively during the study period and 6 months after the last dose of IP. 7\) All HVs who must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 1. Healthy volunteers with history of allergy, including anaphylaxis to food, drugs, or are allergic to any component of the IP considered clinically significant in the Investigator's judgment. 2. Healthy volunteers who are vegans or have medical dietary restrictions. 3. Healthy volunteers with clinically relevant history of respiratory, immunological, dermatological, connective tissue, lymphatic, metabolism, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, urinary, endocrine, neurologic disorders, psychiatric, and/ or any other conditions, judged by the Investigator, that would make the healthy volunteer unsuitable for this study. 4. Healthy volunteers who have acute GI symptoms at screening or admission (e.g., nausea, vomiting, diarrhea, heartburn). 5. Healthy volunteers who have an acute infection such as influenza at screening or admission. 6. Healthy volunteers who have increased risk of infection. 1. With history and/or presence of tuberculosis; positive result for IFN-γ release assay (IGRA) (i.e., QuantiFERON TB-Gold), the test may be repeated if the initial test result is indeterminate. Volunteers who have resided in regions where tuberculosis or mycosis are endemic during 90 days before screening or who intend to visit such a region during the duration of the study. 2. HV who engage in high risk unsafe sexual practices. 3. With active malignancy or neoplastic disease in the previous 5 years other than superficial basal cell carcinoma. 4. With a disease history suggesting abnormal immune function.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai Xuhui Distric Central Hospital
Shanghai, 200031, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A pharmacokinetic study of NTI164 in healthy adult volunteers
- Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa
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