Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.
NCT ID: NCT06657703
Last Updated: 2025-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
38 participants
INTERVENTIONAL
2024-11-25
2026-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HC022 5mg SC
Participants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1.
HC022
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
HC022 50mg SC
Participants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1.
HC022
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
HC022 150mg SC
Participants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1.
HC022
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
HC022 450mg SC
Participants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1.
HC022
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
HC022 900mg SC
Participants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1.
HC022
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Interventions
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HC022
Administered as specified in the treatment arm
Placebo
Administered as specified in the treatment arm
Eligibility Criteria
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Inclusion Criteria
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
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；
18 Years
55 Years
ALL
Yes
Sponsors
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HC Biopharma Inc.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The Clinical Pharmacology Research Center of PUMCH
Beijing, , China
Countries
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Central Contacts
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The Clinical Pharmacology Research Center of PUMCH
Role: CONTACT
Facility Contacts
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Other Identifiers
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HC022-I-001
Identifier Type: -
Identifier Source: org_study_id
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