RecruitingPhase 1NCT06657703

Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.

A Phase Ia Single Center, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Doses of HC022 in Healthy Subjects

Sponsor

HC Biopharma Inc.

Enrollment

38 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

Summary

The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjects；To evaluate the immunogenicity of HC022 administered to healthy subjects.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HC022 and a drug called Placebo for people with systemic lupus erythematosus. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 55 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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