Overview
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.
Description
This is a first-in-human study of HC022 to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single HC022 doses in healthy subjects.
Eligibility
Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements;
- Aged 18 to 55 years old, inclusive, male or female;
- 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)；
- Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and 12-lead ECG；
- 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:
- 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;
- 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)；
- History of or current diagnosis of active tuberculosis (TB), or untreated latent TB infection (LTBI) at screening；
- History of severe herpes infection or zoster viral infection；
- Serious infection, serious injuries, or major surgical procedures within 6 months prior to Screening；
- History of alcohol or substance abuse, a positive urine drug or alcohol test at Day -1；
- History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug；
- Any disease or conditons that are not suitable for participation in this study as determined by the Investigator；