NCT06082323 A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
| NCT ID | NCT06082323 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 127 participants |
| Start Date | 2024-06-13 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 127 participants in total. It began in 2024-06-13 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
LT-002-158 is an oral IRAK4 protein degrader being developed for the treatment of autoimmune disease and inflammation including Hidradenitis Suppurativa and Atopic Dermatitis. This first-in-human (FIH) study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of LT-002-158 in healthy volunteers. The effects of food on the pharmacokinetics of LT-002-158 will also be assessed in healthy volunteers.
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.
Contact & Investigator
Qian Chen, MD
PRINCIPAL INVESTIGATOR
Shanghai Xuhui Central Hospital
Frequently Asked Questions
Who can join the NCT06082323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06082323 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06082323 currently recruiting?
Yes, NCT06082323 is actively recruiting participants. Contact the research team at qchen@shxh-centerlab.com for enrollment information.
Where is the NCT06082323 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06082323 clinical trial?
NCT06082323 is sponsored by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.. The principal investigator is Qian Chen, MD at Shanghai Xuhui Central Hospital. The trial plans to enroll 127 participants.