A Study to Investigate the Safety and Tolerability of CAN10 Antibody in Healthy Subjects and in Subjects With Plaque Psoriasis.

Sponsor ID
CAN10CLIN001
Clinicaltrials.gov ID
NCT06143371
EudraCT ID
2023-504450-35
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
CAN10CLIN001
Trial Details
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Age
18 - 50 Years
Therapeutic Area
  • Healthy Volunteers
    • Sex
    Female & Male
    Trial Dates
    Aug 2023 - Nov 2025
    Healthy Volunteers
    Yes
    • Male or female, aged 18 to 50 years of age (inclusive) at the time of signing informed consent.
    • Body mass index (BMI) 18 to 30 kg/m2 (inclusive) and a weight between 50 to 100 kg (inclusive) at the time of screening
    • Considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
    • Female subjects of childbearing potential must use a highly effective method of birth control and have a negative pregnancy test at screening and before the first dose of study drug. Male subjects with female partners must agree to use a condom, and their female partners are recommended to use a highly effective method of birth control.
    • Additionally for subjects with plaque psoriasis only:
    • A diagnosis of plaque psoriasis with Psoriasis Area Severity Index (PASI) score ≥3 to ≤15 and Physician Global Assessment (PGA) score ≥2 (mild) to \<4 (moderate).
    • No disease manifestation requiring systemic immunosuppressive therapy.
    • History or presence of:
    • Severe allergy/hypersensitivity (subjects with mild pollen allergy can be included).
    • Significant kidney, liver, or urologic disease.
    • Clinically significant psychiatric disorders
    • Tuberculosis (TB) infection or positive QuantiFERON TB Gold test
    • Any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
    • Clinically significant illness, medical/surgical procedure, or trauma within 4 weeks before the first dose of study drug.
    • Ongoing opportunistic or systemic infections
    • A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibodies at screening.
    • Additionally for subjects with plaque psoriasis only:
    • Psoriasis other than a plaque variant.
    • Any sign of infection of any of the psoriatic lesions.
    • Use of any of the following treatments within the indicated washout period before the first dose of study drug:
    • 12 weeks or 5 half-lives (whichever is longer) for biologic agents known or expected to impact the course of psoriasis or its assessments.
    • 12 weeks for oral retinoids
    • 8 weeks for cyclosporin, interferon, methotrexate, other systemic immunosuppressive or immunomodulating agents, or psoralen plus ultraviolet A (UVA)
    • 2 weeks for immunizations or drugs known to possibly worsen psoriasis, unless on a stable dose for \>12 weeks
    • 1 week for topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives, retinoids, or coal tar (used on the body)

    Study Summary

    This is a first-in-human, randomized, double- blind, placebo-controlled, dose escalation study to investigate how different doses of CAN10 are tolerated, taken up by the body and how long CAN10 stays in the body. In the first part of the study, the single ascending dose (SAD) cohorts, CAN10 will be given as a single intravenous dose to healthy subjects. In the second part of the study, the multiple ascending dose (MAD) cohorts, CAN10 will be given as repeated subcutaneous doses to participants with mild to moderate plaque psoriasis.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Biological: CAN10
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    80
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male or female, aged 18 to 50 years of age (inclusive) at the time of signing informed consent.
    • * Body mass index (BMI) 18 to 30 kg/m2 (inclusive) and a weight between 50 to 100 kg (inclusive) at the time of screening

    Exclusion Criteria

    • * History or presence of:
    • 1. Severe allergy/hypersensitivity (subjects with mild pollen allergy can be included).
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female, aged 18 to 50 years of age (inclusive) at the time of signing informed consent.
    • Body mass index (BMI) 18 to 30 kg/m2 (inclusive) and a weight between 50 to 100 kg (inclusive) at the time of screening
    • Considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
    • Female subjects of childbearing potential must use a highly effective method of birth control and have a negative pregnancy test at screening and before the first dose of study drug. Male subjects with female partners must agree to use a condom, and their female partners are recommended to use a highly effective method of birth control.
    • Additionally for subjects with plaque psoriasis only:
    • A diagnosis of plaque psoriasis with Psoriasis Area Severity Index (PASI) score ≥3 to ≤15 and Physician Global Assessment (PGA) score ≥2 (mild) to \<4 (moderate).
    • No disease manifestation requiring systemic immunosuppressive therapy.
    Exclusion Criteria:
    • History or presence of:
    • Severe allergy/hypersensitivity (subjects with mild pollen allergy can be included).
    • Significant kidney, liver, or urologic disease.
    • Clinically significant psychiatric disorders
    • Tuberculosis (TB) infection or positive QuantiFERON TB Gold test
    • Any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
    • Clinically significant illness, medical/surgical procedure, or trauma within 4 weeks before the first dose of study drug.
    • Ongoing opportunistic or systemic infections
    • A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antigen or antibodies at screening.
    • Additionally for subjects with plaque psoriasis only:
    • Psoriasis other than a plaque variant.
    • Any sign of infection of any of the psoriatic lesions.
    • Use of any of the following treatments within the indicated washout period before the first dose of study drug:
    • 12 weeks or 5 half-lives (whichever is longer) for biologic agents known or expected to impact the course of psoriasis or its assessments.
    • 12 weeks for oral retinoids
    • 8 weeks for cyclosporin, interferon, methotrexate, other systemic immunosuppressive or immunomodulating agents, or psoralen plus ultraviolet A (UVA)
    • 2 weeks for immunizations or drugs known to possibly worsen psoriasis, unless on a stable dose for \>12 weeks
    • 1 week for topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives, retinoids, or coal tar (used on the body)

    Locations

    Location
    Status
    Location
    CRS Clinical Research Services Berlin GmbH
    Berlin, Germany, 13627
    Status
    N/A

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