A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
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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