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NCT Number: NCT06657703

Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.

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.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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

  • 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;

Treatment and study plan

HC022

Drug

Administered as specified in the treatment arm

Placebo

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 20 weeks

Secondary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022

    Time frame: Up to 20 weeks

  2. Maximum Observed Concentration (Cmax) of HC022

    Time frame: Up to 20 weeks

  3. Time to Reach Maximum Observed Concentration (Tmax) of HC022

    Time frame: Up to 20 weeks

  4. Terminal Elimination Half-Life (t1/2) of HC022

    Time frame: Up to 20 weeks

  5. Apparent Clearance (CL/F) of HC022

    Time frame: Up to 20 weeks

  6. Apparent Volume of Distribution (Vz/F) of HC022

    Time frame: Up to 20 weeks

  7. Number of Participants Who Develop Serum Anti-HC022 Antibodies

    Time frame: Up to 20 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Langxi Zhang, PhD

CONTACT

[email protected]

8602150433368

The Clinical Pharmacology Research Center of PUMCH

CONTACT

Sponsors and collaborators

Lead sponsor

HC Biopharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 24, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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