A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers

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About the study

The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  • For healthy subject cohorts,
  • Inclusion Criteria:


    1. Non-smoking adult healthy male and female, aged 18 to 65 years (inclusive), at the time of consent with a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive), at Screening.
    2. Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray

    EXCLUSION CRITERIA

    Exclusion Criteria:


    1. Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment
    2. Laboratory test results outside the local reference range and deemed clinically significant
    3. History of chronic medications, immunosuppressant or steroids
    4. History of malignant neoplasm
    5. History of relevant atopy
    6. History of hypersensitivity to biologic agents or any of the excipients in the formulation.
    7. Excessive xanthine consumption
    8. History of drug or alcohol addiction or dependence within 1 year
    9. Positive of a tuberculosis test or a history of tuberculosis
    10. Abnormal blood pressure and/or ECG parameters
    11. Any prescribed medications within 28 days or nonprescription drugs within 7 days
    12. Previously received aldesleukin or any other IL-2 derivative

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition
    Systemic Lupus Erythematosus
    Age (in years)
    18 - 65
    Phase
    Phase 1
    Participants needed
    32
    Est. Completion Date
    Dec 31, 2023
    Treatment type
    Interventional

    Sponsor
    Cugene Inc.
    ClinicalTrials.gov identifier
    NCT05328557
    Study number
    CUG252-P101

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