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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Shanghai Xuhui Distric Central Hospital
RECRUITING
Shanghai
Contact Information
Primary
Qian Chen, MD
qchen@shxh-centerlab.com
+86-012-54036058
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 127
Treatments
Experimental: Single Ascending Dose (SAD)
Part 1: healthy volunteer subject cohorts randomized 6:2 receiving a single dose of LT-002-158 or placebo. The first cohort will receive 50mg of LT-002-158 or placebo. Dose escalation will occur if LT-002-158 or placebo is tolerated.
Experimental: Food effect
Part 2: A 3-treatment, 3 period crossover study will be conducted, which is composed of 15 healthy Volunteer subjects, who will be receiving a single dose of LT-002-158 in fasted, standard meal and high fat meal.
Experimental: Multiple Ascending Doses (MAD) Study
Part 3: Healthy volunteer subject cohorts randomized 8:2 to receive LT-002-158 or placebo for 14 days continuous dosing. The first cohort will receive a dose of LT-002-15 or placebo determined to be safe based on data generated in the SAD portion and FE study.
Sponsors
Leads: Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.

This content was sourced from clinicaltrials.gov

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