Study of CUG252 in Healthy Volunteers and in Patients With Systemic Lupus Erythematosus

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects, and multiple escalating subcutaneous doses of CUG252 in patients with mild to moderate Systemic Lupus Erythematosus (SLE)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cugene Inc.

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

For patients with SLE cohorts,

Inclusion Criteria:

• Male and female patients, aged 18 to 75 years (inclusive), at the time of consent with BMI between 18.0 and 32.0 kg/m2 (inclusive), at Screening

• Fulfills classification criteria for SLE according to the 2019 EULAR/ACR classification criteria

• Stable mild-to-moderate SLE disease activity for ≥ 8 weeks with SLEDAI ≤ 10 or Cutaneous Lupus Erythematosus Disease Area and

• Severity Index- Activity (CLASI-A) score ≤ 20

• Oral prednisone, Azathioprine, antimalarial, mycophenolate and methotrexate are allowed at a stable dose

Exclusion Criteria:

• History of, or current diagnosis of, a clinically significant non-SLE-related vasculitis syndrome

• Active severe or unstable neuropsychiatric SLE

• Active severe renal disease or history of severe active lupus nephritis

• Diagnosis (within 1 year of Screening) of mixed connective tissue disease or any history of syndromes overlapping with SLE

• Diagnosis of fibromyalgia

• Prosthetic joint infection within 3 years of Screening or native joint infection within 1 year prior to Screening

• History of hypersensitivity to biologics drug

• Prior administration of aldesleukin, or other IL-2 derivatives

• History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than 2 weeks within the last 48 weeks prior to Screening

• Current active bacterial, viral, or fungal infection

• Active tuberculosis (TB) on the basis of positive medical history or chest radiograph OR evidence of latent TB by positive

• Screening chest X-ray indicating evidence of a pulmonary infection, pneumonitis or other active lung disease

• History of organ or bone marrow transplant

• Clinically significant ECG abnormalities

• Evidence of significant hematologic, hepatic, or renal dysfunction

• History of any significant cardiovascular diseases

• History of drug or alcohol addiction or dependence within 1 year of Screening

• History of GI bleeding, bowel ischemia/perforation

• History of cancer, apart from successfully treated Squamous or basal cell carcinoma of the skin, cervical cancer in situ or breast ductal carcinoma in situ within 5 years

• Currently on hydroxychloroquine or chloroquine with eye exam evidence of retinopathy within 6 months of Screening

• Presence of one or more significant concurrent medical conditions per Investigator judgment