Evaluating the safety and tolerability of HC022 in healthy individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 study aims to assess the safety, tolerability, and pharmacokinetics of single doses of HC022 administered subcutaneously to healthy subjects. The study will involve a single-ascending dose design, where participants will receive varying doses of HC022 to determine the appropriate dosing and monitor any adverse effects. Additionally, the study will evaluate the immunogenicity of HC022 in this population. The findings will help establish the drug's safety profile before further testing in patients with systemic lupus erythematosus.

Why it matters

Who can join: the full rules

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；

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting
• The Clinical Pharmacology Research Center of PUMCH
  Beijing, China Recruiting
• Peking Union Medical College Hospital
  Beijing, China Not yet recruiting

Study contacts

• Study coordinator: Langxi Zhang, PhD
• Email: langxi.zhang@btyy.com
• Phone: 8602150433368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.