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

Study Overview
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Brief Summary
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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
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This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.

Official Title
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Phase Ia, Randomized Double-Blinded, Placebo-Controlled Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 Following a Single Dose Administration in Normal Health Volunteers.

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: CUG252
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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For healthy subject cohorts, 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CUG252<br>Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. | Drug: CUG252<br>* CUG252 will be administered by subcutaneous (SC) injection<br>|
| Placebo Comparator: Placebo<br>Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. | Drug: Placebo<br>* Placebo will be administered by subcutaneous (SC) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of subjects with Treatment Emergent Adverse Events | To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects. | Up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics profile of CUG252 (AUC) | To assess the Area under the plasma concentration versus time curve (AUC) | Up to 10 weeks | 
| Pharmacokinetics profile of CUG252 (Cmax) | To assess the maximum plasma concentration (Cmax) | Up to 10 weeks | 
| Pharmacokinetics profile of CUG252 (Tmax) | To assess the time of maximum concentration (Tmax) | Up to 10 weeks | 
| Pharmacokinetics profile of CUG252 (t1/2) | To assess the half-life (t1/2) | Up to 10 weeks | 
| Immunogenicity of CUG252 | To measure the serum concentration of antibodies against CUG252 | Up to 10 weeks | 
| Change in the number and percentages of immune cells | To assess the effect of CUG252 on immuno-pharmacodynamic endpoints. | Up to 10 weeks |