Status:
COMPLETED
A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
Lead Sponsor:
Cugene Inc.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
Detailed Description
This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05328557
Start Date
November 9 2021
End Date
August 3 2022
Last Update
February 20 2025
Active Locations (1)
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1
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, United States, 66212