RecruitingPhase 1NCT07177911

Safety and Efficacy Study of CC312 for Moderate to Severe SLE

A Phase I Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of CC312 in Patients With Moderate-to-Severe Systemic Lupus Erythematosus

Sponsor

CytoCares Inc

Enrollment

32 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

SLE - Systemic Lupus Erythematosus

Summary

This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of CC312 in adult patients with moderate to severe systemic lupus erythematosus (SLE).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CC312 and a drug called Placebo for people with sle - systemic lupus erythematosus. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCC312

Subjects will initially receive a single intravenous dose of CC312. After a 21-day period following the first dose, the patient may proceed to the multiple intravenous dosing phase only after investigators and the sponsor have confirmed acceptable safety and tolerability.

DRUGPlacebo

Subjects will initially receive a single intravenous dose of Placebo. After a 21-day period following the first dose, the patient may proceed to the multiple intravenous dosing phase only after investigators and the sponsor have confirmed acceptable safety and tolerability.