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

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: CUG252; Drug: Placebo

• Registration Number: NCT05328557
• Lead Sponsor: Cugene Inc.

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.

Study Timeline

• Study Start: 2021-11-09
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CUG252	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number and percentage of subjects with Treatment Emergent Adverse Events	Up to 10 weeks	To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Altasciences Clinical Kansas, Inc.; 🇺🇸 Overland Park, Kansas, United States