Systemic Lupus Erythematosus
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGHC022
Administered as specified in the treatment arm
DRUGPlacebo
Administered as specified in the treatment arm
Sponsors
HC Biopharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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；
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Concentration (Cmax) of HC022 | Up to 20 weeks |
| Time to Reach Maximum Observed Concentration (Tmax) of HC022 | Up to 20 weeks |
| Terminal Elimination Half-Life (t1/2) of HC022 | Up to 20 weeks |
| Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022 | Up to 20 weeks |
| Apparent Volume of Distribution (Vz/F) of HC022 | Up to 20 weeks |
| Number of Participants Who Develop Serum Anti-HC022 Antibodies | Up to 20 weeks |
| Apparent Clearance (CL/F) of HC022 | Up to 20 weeks |
Countries
China
Contacts
Primary ContactLangxi Zhang, PhD
Backup ContactThe Clinical Pharmacology Research Center of PUMCH
Outcome results
None listed