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

NCT05328557 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CUG252-P101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pharmacokinetics profile of CUG252 (AUC)

  Up to 10 weeks

• Pharmacokinetics profile of CUG252 (Cmax)

  Up to 10 weeks

• Pharmacokinetics profile of CUG252 (Tmax)

  Up to 10 weeks

• Pharmacokinetics profile of CUG252 (t1/2)

  Up to 10 weeks

• Immunogenicity of CUG252

  Up to 10 weeks

Study Arms (2)

CUG252

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

CUG252 DRUG

CUG252 will be administered by subcutaneous (SC) injection

CUG252

Placebo DRUG

Placebo will be administered by subcutaneous (SC) injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cugene Inc.: lead

Study Sites (1)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Martin K Kankam, MD, PhD

  Altasciences Company Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 14, 2022
• Study Start: November 9, 2021
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

US (1)