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

Cugene

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: CUG252; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05328557

CUG252-P101

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups, including a placebo group

CUG252

Experimental group

Description:

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.

Treatment:

Drug: CUG252

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo