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.
Overview
- Phase
- Phase 1
- Intervention
- CUG252
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Cugene Inc.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number and percentage of subjects with Treatment Emergent Adverse Events
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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
- •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
Arms & Interventions
CUG252
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.
Intervention: CUG252
Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Number and percentage of subjects with Treatment Emergent Adverse Events
Time Frame: Up to 10 weeks
To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects.
Secondary Outcomes
- Pharmacokinetics profile of CUG252 (AUC)(Up to 10 weeks)
- Pharmacokinetics profile of CUG252 (Cmax)(Up to 10 weeks)
- Pharmacokinetics profile of CUG252 (Tmax)(Up to 10 weeks)
- Pharmacokinetics profile of CUG252 (t1/2)(Up to 10 weeks)
- Change in the number and percentages of immune cells(Up to 10 weeks)
- Immunogenicity of CUG252(Up to 10 weeks)