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

Primary Purpose

Hidradenitis Suppurativa, Atopic Dermatitis, Healthy Volunteer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
LT-002-158/Placebo oral tablet(s)
Sponsored by
Shanghai Leadingtac Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Single Ascending Dose (SAD) and Food Effect (FE) Study

    Multiple Ascending Doses (MAD) Study

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    To evaluate the safety and tolerability of LT-002-158 following single dose in HVs
    Incidence and severity of treatment emergent Adverse Events

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 9, 2023
    Sponsor
    Shanghai Leadingtac Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06082323
    Brief Title
    A Phase 1 Study of LT-002-158 Intended for the Treatment of Skind Disorder in Healthy Adult Volunteers
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 10, 2024 (Anticipated)
    Primary Completion Date
    November 10, 2024 (Anticipated)
    Study Completion Date
    February 10, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Leadingtac Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hidradenitis Suppurativa, Atopic Dermatitis, Healthy Volunteer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Ascending Dose (SAD) and Food Effect (FE) Study
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Multiple Ascending Doses (MAD) Study
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    LT-002-158/Placebo oral tablet(s)
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    To evaluate the safety and tolerability of LT-002-158 following single dose in HVs
    Description
    Incidence and severity of treatment emergent Adverse Events
    Time Frame
    up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31604104
    Citation
    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.
    Results Reference
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    A Phase 1 Study of LT-002-158 Intended for the Treatment of Skind Disorder in Healthy Adult Volunteers

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