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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: CUG252; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Altasciences Clinical Kansas, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: CUG252; CUG252 will be administered by subcutaneous (SC) injection
Placebo Comparator: 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.	Drug: Placebo; Placebo will be administered by subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cugene Inc.
• Investigators: Principal Investigator: Martin K Kankam, MD, PhD, Altasciences

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: CUG252-P101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No