Clinical trial NCT05328557: A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Cugene Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Number and percentage of subjects with Treatment Emergent Adverse Events
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Pharmacokinetics profile of CUG252 (AUC)
timeFrame: Up to 10 weeks
measure: Pharmacokinetics profile of CUG252 (Cmax)
timeFrame: Up to 10 weeks
measure: Pharmacokinetics profile of CUG252 (Tmax)
timeFrame: Up to 10 weeks
measure: Pharmacokinetics profile of CUG252 (t1/2)
timeFrame: Up to 10 weeks
measure: Immunogenicity of CUG252
timeFrame: Up to 10 weeks
measure: Change in the number and percentages of immune cells
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas, Inc.
state: Kansas
Study officials:
affiliation: Altasciences Company Inc.
name: Martin K Kankam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: