Hidradenitis suppurativa: Epidemiology, clinical presentation, and pathogenesis.
Samantha R Goldburg, Bruce E Strober, Michael J Payette
https://pubmed.ncbi.nlm.nih.gov/31604104Actively Recruiting
Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID06082323
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
Led by Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Updated on 2025-02-19
127
Participants Needed
1
Research Sites
8 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating LT-002-158, an oral IRAK4 protein degrader being developed to treat autoimmune diseases and inflammation, including Hidradenitis Suppurativa and Atopic Dermatitis. This first-in-human Phase 1 study aims to assess the safety, tolerability, and how the drug is absorbed and processed in the body (pharmacokinetics and pharmacodynamics) in healthy adult volunteers. The study also examines how food intake affects the drug's absorption. The trial includes three parts: Part 1 involves single ascending doses where groups of healthy volunteers receive either LT-002-158 or placebo, starting at 50 mg, with doses increasing if tolerated. Part 2 is a crossover study with healthy volunteers receiving a single dose of LT-002-158 under different food conditions (fasted, standard meal, and high-fat meal) to evaluate food effects. Part 3 involves multiple ascending doses given daily for 14 days, with dosing levels determined based on earlier safety and pharmacokinetic data. Participants will be closely monitored through physical exams, vital signs, ECGs, laboratory tests, and pregnancy tests for women. Researchers will track safety and how the drug behaves in the body up to 28 days after dosing. Volunteers must comply with scheduled visits and procedures throughout the study, which is expected to run until June 2025.
CONDITIONS
Brief Title
A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers
Who Can Participate
Age: 18Years - 55Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy volunteers who understand the study and can give written informed consent
- Male or female aged 18 to 55 years inclusive at consent
- Body mass index between 18 and 30 kg/m2 inclusive
- Body weight of at least 50.0 kg for males and 45.0 kg for females
- Negative SARS-CoV-2 test on Day -2 (admission)
- Good health with no significant medical history confirmed by physical exam, vital signs, ECG, lab tests, and serum virology
- Females must be non-pregnant, non-lactating, with negative pregnancy test at screening
- Males and females must agree to use effective contraception from screening to 6 months after last dose
- Willing and able to comply with visits, treatment, labs, and procedures
You will not qualify if you...
- History of allergy or anaphylaxis to food, drugs, or study drug components
- Vegan diet or medical dietary restrictions
- Relevant history of respiratory, immune, skin, connective tissue, lymphatic, metabolic, liver, kidney, blood, lung, heart, stomach, muscle, urinary, hormone, nerve, psychiatric, or other disorders making participation unsuitable
- Acute gastrointestinal symptoms at screening or admission (e.g., nausea, vomiting, diarrhea, heartburn)
- Acute infections such as influenza at screening or admission
- Increased risk of infection including history or presence of tuberculosis or positive IGRA test
- Residing in or intending to visit regions endemic for tuberculosis or mycosis within 90 days before or during the study
- Engaging in high-risk unsafe sexual practices
- Active cancer or neoplastic disease in the past 5 years except superficial basal cell carcinoma
- History suggesting abnormal immune function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening assessments including physical exam, vital signs, ECG, lab tests, and pregnancy test
Treatment
Duration - Up to 28 days including single dose, crossover, and 14-day multiple dose periods
Participants receive LT-002-158 or placebo through single ascending doses, a food effect crossover study, and multiple ascending doses over 14 days to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits depending on assigned cohort: single dose administration, 3 crossover treatment periods, and daily dosing visits for 14 days
Trial Site Locations
Total: 1 location
1
Shanghai Xuhui Distric Central Hospital
Shanghai, China, 200031
Actively Recruiting
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Research Team
Q
Qian Chen, MD
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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