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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05328557

Enrollment

Registered

2022-04-14

Start date

2021-11-09

Completion date

2022-08-03

Last updated

2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

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.

Interventions

DRUGCUG252

CUG252 will be administered by subcutaneous (SC) injection

DRUGPlacebo

Placebo will be administered by subcutaneous (SC) injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 (AUC)	Up to 10 weeks	To assess the Area under the plasma concentration versus time curve (AUC)
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.
Pharmacokinetics profile of CUG252 (t1/2)	Up to 10 weeks	To assess the half-life (t1/2)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026