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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
ClinicalTrials.gov ID: NCT06657703
What this study is testing
What is HC022?
HC022 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and...
- All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months (for female) or 3...
You likely can't join if
- Have participated in other clinical trials within 3 months, or within the 5 half lives of the investigational drug prior to screening, whichever is...
- History of or positive test results at screening for the following: for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab)...
- 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；
See the full eligibility 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；
- 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；
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.