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CUG252 for Lupus

Phase 1

Waitlist Available

Led By Martin K Kankam, MD, PhD

Research Sponsored by Cugene Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 weeks

Awards & highlights

Study Summary

This trial is testing a new drug for lupus to see if it is safe and tolerated by patients.

Who is the study for?

This trial is for non-smoking adults aged 18-65 with a BMI of 18.0 to 32.0 kg/m2, who are generally healthy as confirmed by medical exams and tests. People with tuberculosis, infections, chronic medication use including immunosuppressants or steroids, drug/alcohol addiction within the past year, cancer history, significant allergies or abnormal test results can't participate.Check my eligibility

What is being tested?

The study is testing CUG252's safety when given in increasing doses under the skin to healthy volunteers compared to a placebo (a substance with no active drug). It aims to understand how well people tolerate it and what happens inside the body after taking it.See study design

What are the potential side effects?

Potential side effects aren't specified but may include reactions at the injection site, general discomfort or changes in vital signs like blood pressure and heart rate since this is an early-phase trial assessing tolerability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and percentage of subjects with Treatment Emergent Adverse Events

Secondary outcome measures

Change in the number and percentages of immune cells

Immunogenicity of CUG252

Pharmacokinetics profile of CUG252 (AUC)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CUG252Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cugene Inc.Lead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

Martin K Kankam, MD, PhDPrincipal InvestigatorAltasciences Company Inc.

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

CUG252 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05328557 — Phase 1

Lupus Research Study Groups: CUG252, Placebo

Lupus Clinical Trial 2023: CUG252 Highlights & Side Effects. Trial Name: NCT05328557 — Phase 1

CUG252 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05328557 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for this trial restricted to those younger than 45?

"This research is open to individuals aged 18 through 65."

Answered by AI

Is recruitment for this trial still ongoing?

"The information on clinicaltrials.gov reveals that this medical trial is not currently recruiting patients; the study was initially posted in November 2021 and the most recent update occurred a year later. Nevertheless, 124 other studies are actively looking for volunteers at this moment."

Answered by AI

Are there any potential deleterious effects of CUG252 on patients?

"The scant evidence available suggests that CUG252 is safe, awarding it a score of 1."

Answered by AI

Is there an opportunity for me to join this research?

"This medical experiment is recruiting 32 participants with lupus erythematosus, systemic for a period of time between 18 and 65 years old. To be considered as an eligible subject, one must satisfy the following: non-smoking adult male or female aged eighteen to sixty-five (inclusive) at consenting with BMI ranging from 18.0 up to 32.0 kg/m2 (inclusive), healthy by medical history, physical examination, vital signs & clinical lab safety tests assessment; ECG and chest X-ray too."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05328557.