A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
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Lead
Cugene Inc.
This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
For healthy subject cohorts,
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.
Healthy as determined by medical history, physical examination, vital signs, clinical laboratory safety tests, ECG, and chest X-ray
You may not be if
Active bacterial, viral, fungal infection or known inflammatory process, infection or antibiotic treatment
Laboratory test results outside the local reference range and deemed clinically significant
History of chronic medications, immunosuppressant or steroids
History of malignant neoplasm
History of relevant atopy
History of hypersensitivity to biologic agents or any of the excipients in the formulation.
Excessive xanthine consumption
History of drug or alcohol addiction or dependence within 1 year
Positive of a tuberculosis test or a history of tuberculosis
Abnormal blood pressure and/or ECG parameters
Any prescribed medications within 28 days or nonprescription drugs within 7 days
Previously received aldesleukin or any other IL-2 derivative
Clareo Health | A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
