A Single and Multiple Ascending Dose Trial of LT-002-158 Tablets in Healthy Adult Volunteers

Last updated: February 16, 2025
Sponsor: Shanghai Leadingtac Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Allergy

Rash

Acne Inversa

Treatment

LT-002-158/Placebo oral tablet(s)

Clinical Study ID

NCT06082323
LT2158CHN001V6
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Healthy volunteers who fully understand the content, process, and possibleadverse 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 ofsigning 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 onDay -2 (admission).

  5. Healthy volunteers with no significant medical history judged by theInvestigator 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 serumpregnancy test at screening. Women of child bearing potential and males must bewilling to use highly effective acceptable forms of contraception fromscreening to 6 months after the last study drug administration. Males andfemales must be willing to avoid donating sperm or egg respectively during thestudy period and 6 months after the last dose of IP.

  7. All HVs who must be willing and able to comply with scheduled visits, treatmentplan, laboratory tests, and other study procedures.

Exclusion

Exclusion Criteria:

  1. Healthy volunteers with history of allergy, including anaphylaxis to food, drugs, orare allergic to any component of the IP considered clinically significant in theInvestigator'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, judgedby the Investigator, that would make the healthy volunteer unsuitable for thisstudy.

  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 oradmission.

  6. Healthy volunteers who have increased risk of infection.

  7. With history and/or presence of tuberculosis; positive result for IFN-γ releaseassay (IGRA) (i.e., QuantiFERON TB-Gold), the test may be repeated if theinitial test result is indeterminate. Volunteers who have resided in regionswhere tuberculosis or mycosis are endemic during 90 days before screening orwho intend to visit such a region during the duration of the study.

  8. HV who engage in high risk unsafe sexual practices.

  9. With active malignancy or neoplastic disease in the previous 5 years other thansuperficial basal cell carcinoma.

  10. With a disease history suggesting abnormal immune function.

Study Design

Total Participants: 127
Treatment Group(s): 1
Primary Treatment: LT-002-158/Placebo oral tablet(s)
Phase: 1
Study Start date:
June 13, 2024
Estimated Completion Date:
June 01, 2025

Study 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-002-158 after a single dose (Part 1) and after repeated dosing in healthy adult volunteers (Part 3). A 3 treatment, 3-periods crossover design is planned on healthy subjects to understand food effects (FE) on the PK of LT-002-158 (Part 2). Once adequate safety and PK data from multiple SAD cohorts and FE cohort become available, a safe starting dose for the 14-day MAD portion of the study will be selected so as to initiate the enrolment of healthy subjects into 14-day multiple ascending dose (MAD) escalation cohorts.

Connect with a study center

  • Shanghai Xuhui Distric Central Hospital

    Shanghai, 200031
    China

    Active - Recruiting

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