Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHC Biopharma Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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；
Disqualifiers
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；
Trial design
Treatments tested in this trial
- HC022
- Placebo
Treatment groups
38 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov