Actively Recruiting
A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
Led by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Updated on 2025-02-19
127
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers who understand the study and can give written consent
- Male or female aged 18 to 55 years
- Body mass index between 18 and 30 kg/m2
- Weight at least 50.0 kg for males and 45.0 kg for females
- Negative SARS-CoV-2 test on Day -2 (admission)
- No significant medical history and in good health based on exams and lab tests
- Females must be non-pregnant and non-lactating with negative pregnancy test
- Willingness to use effective contraception from screening to 6 months after last dose
- Willingness to avoid sperm or egg donation during study and 6 months after last dose
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- History of allergy including anaphylaxis to food, drugs, or any study drug component
- Vegan diet or medical dietary restrictions
- History of relevant respiratory, immune, skin, connective tissue, lymphatic, metabolic, liver, kidney, blood, lung, heart, digestive, muscle, urinary, hormone, nerve, psychiatric, or other disorders
- Acute gastrointestinal symptoms at screening or admission (nausea, vomiting, diarrhea, heartburn)
- Acute infections like influenza at screening or admission
- Increased risk of infection, including tuberculosis history or positive TB test, residence in endemic regions, or unsafe sexual practices
- Active cancer or cancer in last 5 years except superficial basal cell carcinoma
- History suggesting abnormal immune function
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Xuhui Distric Central Hospital
Shanghai, China, 200031
Actively Recruiting
Research Team
Q
Qian Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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