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CompletedNCT05328557Updated Feb 20, 2025

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

A Phase 1 interventional study of CUG252 and Placebo in Systemic Lupus Erythematosus, sponsored by Cugene Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Cugene Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2022, 4 years 2 months ago, and no results have been posted to the registry.
  • Registered 4 months after the study started (first participant enrolled Nov 2021, registered Mar 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.

02

Conditions studied

  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Cugene Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

For healthy subject cohorts,

Inclusion criteria

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugCUG252

    CUG252 will be administered by subcutaneous (SC) injection

  • DrugPlacebo

    Placebo will be administered by subcutaneous (SC) injection

06

What researchers measure

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.

    Time frame: Up to 10 weeks

Secondary outcomes

  1. Pharmacokinetics profile of CUG252 (AUC)

    To assess the Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to 10 weeks

  2. Pharmacokinetics profile of CUG252 (Cmax)

    To assess the maximum plasma concentration (Cmax)

    Time frame: Up to 10 weeks

  3. Pharmacokinetics profile of CUG252 (Tmax)

    To assess the time of maximum concentration (Tmax)

    Time frame: Up to 10 weeks

  4. Pharmacokinetics profile of CUG252 (t1/2)

    To assess the half-life (t1/2)

    Time frame: Up to 10 weeks

  5. Immunogenicity of CUG252

    To measure the serum concentration of antibodies against CUG252

    Time frame: Up to 10 weeks

  6. Change in the number and percentages of immune cells

    To assess the effect of CUG252 on immuno-pharmacodynamic endpoints.

    Time frame: Up to 10 weeks

07

Study locations

1 site
  • Altasciences Clinical Kansas, Inc.
    Overland Park, Kansas 66212, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05328557
Lead sponsor
Cugene Inc.
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
Nov 9, 2021
Primary completion
Aug 3, 2022
Completion
Aug 3, 2022
Last update
Feb 20, 2025

Study contacts

Martin K Kankam, MD, PhD
principal investigator · Altasciences Company Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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