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

Launched by HC BIOPHARMA INC. · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called HC022 to see how safe it is and how well it is tolerated when given as a single injection under the skin to healthy volunteers. The main goal is to determine if this drug is safe to use, while also looking at how the body processes it and whether it triggers any immune response. The trial is currently looking for participants aged 18 to 55 who are in good health and meet certain weight and body mass index requirements.

If you decide to participate, you will need to understand the study's purpose and risks and sign an informed consent form. Participants will undergo medical assessments to ensure they are healthy and will be expected to follow specific guidelines during the study, including using effective birth control if they are able to have children. This trial is an important step in testing HC022 for future use in people with systemic lupus erythematosus, a disease that affects the immune system. It's a chance to contribute to medical research and help improve treatments for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements;
• • 2. Aged 18 to 55 years old, inclusive, male or female;
• • 3. 3.A body weigh ≥ 50 kg for male , and a body weigh ≥ 45 kg for female, and must have a body mass index between 19 and 28 kilogram per square meter (kg/m2)；
• • 4. Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and 12-lead ECG；
• • 5. All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months (for female) or 3 months (for male) after their dose of study treatment；
• Exclusion Criteria:
• • 1. Have participated in other clinical trials within 3 months, or within the 5 half lives of the investigational drug prior to screening, whichever is longer;
• • 2. History of or positive test results at screening for the following: for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), hepatitis B virus (defined as positive for HBsAg or HBcAb or HBeAg)；
• • 3. History of or current diagnosis of active tuberculosis (TB), or untreated latent TB infection (LTBI) at screening；
• • 4. History of severe herpes infection or zoster viral infection；
• • 5. Serious infection, serious injuries, or major surgical procedures within 6 months prior to Screening；
• • 6. History of alcohol or substance abuse, a positive urine drug or alcohol test at Day -1；
• • 7. History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug；
• • 8. Any disease or conditons that are not suitable for participation in this study as determined by the Investigator；