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
1 other identifier
interventional
38
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedStudy Start
First participant enrolled
November 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2026
CompletedApril 17, 2025
April 1, 2025
9 months
October 18, 2024
April 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 20 weeks
Secondary Outcomes (7)
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022
Up to 20 weeks
Maximum Observed Concentration (Cmax) of HC022
Up to 20 weeks
Time to Reach Maximum Observed Concentration (Tmax) of HC022
Up to 20 weeks
Terminal Elimination Half-Life (t1/2) of HC022
Up to 20 weeks
Apparent Clearance (CL/F) of HC022
Up to 20 weeks
- +2 more secondary outcomes
Study Arms (5)
HC022 5mg SC
EXPERIMENTALParticipants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1.
HC022 50mg SC
EXPERIMENTALParticipants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1.
HC022 150mg SC
EXPERIMENTALParticipants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1.
HC022 450mg SC
EXPERIMENTALParticipants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1.
HC022 900mg SC
EXPERIMENTALParticipants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1.
Interventions
Eligibility Criteria
You may qualify 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;
- 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；
You may not qualify 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 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；
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Peking Union Medical College Hospital
Beijing, 100730, China
Peking Union Medical College Hospital
Beijing, China
The Clinical Pharmacology Research Center of PUMCH
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
The Clinical Pharmacology Research Center of PUMCH
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2024
First Posted
October 24, 2024
Study Start
November 25, 2024
Primary Completion
August 30, 2025
Study Completion
January 8, 2026
Last Updated
April 17, 2025
Record last verified: 2025-04