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

NCT06082323 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LT2158CHN001V6
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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) 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

Healthy Volunteer; Hidradenitis Suppurativa; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of LT-002-158 following single dose in HVs

  Incidence and severity of treatment emergent Adverse Events

  up to 28 days

Study Arms (3)

Single Ascending Dose (SAD)

EXPERIMENTAL

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.

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

Food effect

EXPERIMENTAL

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.

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

Multiple Ascending Doses (MAD) Study

EXPERIMENTAL

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.

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

Interventions

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

Single ascending dose escalation and multiple ascending dose escalation study followed by an evaluation of food effects on absorption Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Also known as: LT-002-158

Food effect; Multiple Ascending Doses (MAD) Study; Single Ascending Dose (SAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Healthy volunteers who fully understand the content, process, and possible adverse event of the study and capable of giving written informed consent form.
• \) Male or female between 18 and 55 years of age (inclusive), at the time of signing the informed consent form.
• \) 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.
• \) Healthy volunteers who must be confirmed as negative in the SARS-CoV-2 test on Day -2 (admission).
• \) 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.
• \) 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.
• \) All HVs who must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Distric Central Hospital

Shanghai, 200031, China

RECRUITING

Related Publications (1)

• Goldburg SR, Strober BE, Payette MJ. Hidradenitis suppurativa: Epidemiology, clinical presentation, and pathogenesis. J Am Acad Dermatol. 2020 May;82(5):1045-1058. doi: 10.1016/j.jaad.2019.08.090. Epub 2019 Oct 9.

  PMID: 31604104 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Qian Chen, MD

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Chen, MD

CONTACT

+86-012-54036058; qchen@shxh-centerlab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 13, 2023
• Study Start: June 13, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)