Clinical trial NCT06657703: Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: HC Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a first-in-human study of HC022 to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single HC022 doses in healthy subjects.

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 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；

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022
timeFrame: Up to 20 weeks
measure: Maximum Observed Concentration (Cmax) of HC022
timeFrame: Up to 20 weeks
measure: Time to Reach Maximum Observed Concentration (Tmax) of HC022
timeFrame: Up to 20 weeks
measure: Terminal Elimination Half-Life (t1/2) of HC022
timeFrame: Up to 20 weeks
measure: Apparent Clearance (CL/F) of HC022
timeFrame: Up to 20 weeks
measure: Apparent Volume of Distribution (Vz/F) of HC022
timeFrame: Up to 20 weeks
measure: Number of Participants Who Develop Serum Anti-HC022 Antibodies
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Peking
country: China
facility: Peking Union Medical College Hospital
city: Peking
country: China
facility: The Clinical Pharmacology Research Center of PUMCH
Study officials:
References: