Status:
RECRUITING
A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
Lead Sponsor:
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.
Conditions:
Healthy Volunteer
Hidradenitis Suppurativa
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Detailed Description
This is a first-in-human (FIH), Phase 1 randomized, placebo-controlled, single and multiple ascending dose trial of LT-002-158 that will characterize the safety, PK and PD of orally administered LT-00...
Eligibility Criteria
Inclusion
- 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
- 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.
- Healthy volunteers who are vegans or have medical dietary restrictions.
- 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.
- Healthy volunteers who have acute GI symptoms at screening or admission (e.g., nausea, vomiting, diarrhea, heartburn).
- Healthy volunteers who have an acute infection such as influenza at screening or admission.
- Healthy volunteers who have increased risk of infection.
- 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.
- HV who engage in high risk unsafe sexual practices.
- With active malignancy or neoplastic disease in the previous 5 years other than superficial basal cell carcinoma.
- With a disease history suggesting abnormal immune function.
Key Trial Info
Start Date :
June 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT06082323
Start Date
June 13 2024
End Date
June 1 2025
Last Update
February 19 2025
Active Locations (1)
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1
Shanghai Xuhui Distric Central Hospital
Shanghai, China, 200031