NCT06657703RecruitingPhase 1
Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
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
Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 18 Oct 2024
- Start date
- 25 Nov 2024
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- HC Biopharma Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT06657703
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 38
- From 25 Nov 2024 to the primary completion date, 30 Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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;
- Serious infection, serious injuries, or major surgical procedures within 6 months prior to Screening；
Other illness
- 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；
- 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；
Who the study is looking for
- 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；
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The Clinical Pharmacology Research Center of PUMCH Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.