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COMPLETEDPHASE1

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.

NCT05328557•Cugene Inc.

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For healthy subject cohorts,
•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
+2 more criteria

Locations (1)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, United States

Key Dates

Start Date

November 9, 2021

Primary Completion Date

August 3, 2022

Completion Date

August 3, 2022

Last Updated

February 20, 2025

Enrollment

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

CUG252

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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