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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- HC Biopharma Inc.
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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；
Arms & Interventions
HC022 150mg SC
Participants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1.
Intervention: Placebo
HC022 450mg SC
Participants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1.
Intervention: HC022
HC022 450mg SC
Participants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1.
Intervention: Placebo
HC022 900mg SC
Participants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1.
Intervention: HC022
HC022 900mg SC
Participants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1.
Intervention: Placebo
HC022 5mg SC
Participants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1.
Intervention: HC022
HC022 5mg SC
Participants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1.
Intervention: Placebo
HC022 50mg SC
Participants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1.
Intervention: HC022
HC022 50mg SC
Participants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1.
Intervention: Placebo
HC022 150mg SC
Participants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1.
Intervention: HC022
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 20 weeks
Secondary Outcomes
- Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022(Up to 20 weeks)
- 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)
- Apparent Clearance (CL/F) 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)