Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
Recruiting · NCT06657703 · Interventional (participants receive a specific treatment) · Lead sponsor: HC Biopharma Inc.
View the official record on ClinicalTrials.gov →Interventions studied
HC022Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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；
Where it is running
3 locations listed.
- Peking Union Medical College Hospital - Beijing, China
- Peking Union Medical College Hospital - Beijing, China
- The Clinical Pharmacology Research Center of PUMCH - Beijing, China