Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
Recruiting
Phase 1Interventional Study
Systemic Lupus Erythematosus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
38 (estimated)
Sponsor
HC Biopharma Inc. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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…
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;
The Clinical Pharmacology Research Center of PUMCH
CONTACT
What are you hoping to find?
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.