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

Systemic Lupus Erythematosus Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05328557
• Other study ID #: CUG252-P101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 7, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Cugene Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• CUG252
CUG252 will be administered by subcutaneous (SC) injection
• Placebo
Placebo will be administered by subcutaneous (SC) injection

Locations

Country	Name	City	State
United States	Altasciences Clinical Kansas, Inc.	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Cugene Inc.

Country where clinical trial is conducted

United States, 

Outcome

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