Testing LT-002-158 tablets in healthy adults

A Phase 1，Randomized, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered LT-002-158 in Healthy Adult Volunteers

This study is testing a new tablet called LT-002-158 in healthy adults to see how safe it is and how it works in the body, which could help in future treatments for autoimmune diseases.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06082323 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and pharmacokinetics of LT-002-158, an oral IRAK4 protein degrader, in healthy adult volunteers. It consists of a single ascending dose and multiple ascending dose phases, along with a crossover design to assess the effects of food on the drug's pharmacokinetics. The study aims to gather essential data to determine a safe starting dose for further testing in patients with autoimmune diseases like Hidradenitis Suppurativa and Atopic Dermatitis.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 55 with a BMI between 18 and 30.

Not a fit: Patients with significant medical history or those who are pregnant or lactating will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from autoimmune diseases and inflammation.

How similar studies have performed: While this approach is novel, similar studies have shown promise in evaluating the safety and pharmacokinetics of new drug candidates.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Shanghai Xuhui Distric Central Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Qian Chen, MD — Shanghai Xuhui Central Hospital
• Study coordinator: Qian Chen, MD

Conditions Healthy Volunteer; Hidradenitis Suppurativa; Atopic Dermatitis