A Phase 1 Study of LT-002-158 Intended for the Treatment of Skind Disorder in Healthy Adult Volunteers

Study Overview
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Brief Summary
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LT-002-158 is a novel small molecule drug being developed as a potential therapy for the treatment of skin disorder disease includes Hidradenitis Suppurativa and Atopic Dermatitis.

Detailed Description
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This is a first-in-human (FIH), Phase I study of LT-002-158 that will characterize the safety,PK, and PD of LT-002-158 after a single oral dose (Part 1) and multiple oral doses at escalating dose levels (Part 2) in adult HVs. In addition, the effect of food intake on the PK of LT-002-158 will also be explored by selecting one of the SAD cohorts who will return for a second treatment period and will receive the same treatment allocation, but in the fed state.

Official Title
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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 Intended for the Treatment of Skind Disorder in Healthy Adult Volunteers

Conditions
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Hidradenitis Suppurativa, Atopic Dermatitis, Healthy Volunteer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Ascending Dose (SAD) and Food Effect (FE) Study<br>Part 1 is a double-blinded, randomized, placebo-controlled, SAD, sequential group study in 48 adult HVs, divided into 6 cohorts of 8 HVs each and a single arm, for food effect (FE) study. Within each cohort, 6 HVs will be randomized to receive LT-002-158 and 2 HVs will be randomized to receive placebo. | Drug: LT-002-158/Placebo oral tablet(s)<br>* 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)<br>|
| Experimental: Multiple Ascending Doses (MAD) Study<br>Part 2 is a double-blinded, randomized, placebo-controlled, MAD sequential group study in 30 adult HVs, divided into 3 cohorts of 10 adult HVs in each cohort. This MAD study will evaluate 3 dose levels of LT-002-158 once daily for consecutive 14 days. Thirty healthy volunteers will be enrolled into 3 cohorts and within each cohort, 8 HVs will be randomized to receive LT-002-158 and 2 HVs receiving placebo. | Drug: LT-002-158/Placebo oral tablet(s)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |