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Systemic Lupus ErythematosusPhase 1NCT06657703

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

A Phase 1 study testing HC022 in people with Systemic Lupus Erythematosus, run by HC Biopharma Inc. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
HC022
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
3 sitesChina
Study dates
25 Nov 2024to 8 Jan 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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；

Who cannot join

  • 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；

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Langxi Zhang, PhD contact

8602150433368

langxi.zhang@btyy.com

The Clinical Pharmacology Research Center of PUMCH contact

China3 sites, 3 recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Xiaohong Han, PhD, 8613810659230, hanxiaohong@pumch.cn

    XiaoHong Han, PhD

    Not yet recruiting

  • Peking Union Medical College Hospital

    Beijing

    xiaohong Han, 86+13810659230, hanxiaohong@pumch.cn

    Recruiting

  • The Clinical Pharmacology Research Center of PUMCH

    Beijing

    xiaohong Han, 86+13810659230, hanxiaohong@pumch.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
HC022, Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HC022Drug

    Administered as specified in the treatment arm

  • PlaceboDrug

    Administered as specified in the treatment arm

Study groups in NCT06657703
Study groupRoleWhat they receive
HC022 5mg SCExperimentalParticipants will receive single subcutaneous (SC) dose of 5 mg HC022 or matching placebo on Day 1.
Receives: Drug: HC022; Drug: Placebo
HC022 50mg SCExperimentalParticipants will receive single subcutaneous (SC) dose of 50 mg HC022 or matching placebo on Day 1.
Receives: Drug: HC022; Drug: Placebo
HC022 150mg SCExperimentalParticipants will receive single subcutaneous (SC) dose of 150 mg HC022 or matching placebo on Day 1.
Receives: Drug: HC022; Drug: Placebo
HC022 450mg SCExperimentalParticipants will receive single subcutaneous (SC) dose of 450 mg HC022 or matching placebo on Day 1.
Receives: Drug: HC022; Drug: Placebo
HC022 900mg SCExperimentalParticipants will receive single subcutaneous (SC) dose of 900 mg HC022 or matching placebo on Day 1.
Receives: Drug: HC022; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 20 weeks

Secondary outcomes (7)

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

    Measured: Up to 20 weeks

  2. Maximum Observed Concentration (Cmax) of HC022

    Measured: Up to 20 weeks

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

    Measured: Up to 20 weeks

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

    Measured: Up to 20 weeks

  5. Apparent Clearance (CL/F) of HC022

    Measured: Up to 20 weeks

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

    Measured: Up to 20 weeks

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

    Measured: Up to 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start25 Nov 2024
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion8 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06657703
Sponsor's protocol ID
HC022-I-001
Status last verified
Apr 2025
First submitted
18 Oct 2024
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HC022 in people with Systemic Lupus Erythematosus, run by HC Biopharma Inc. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Langxi Zhang, PhD (8602150433368, langxi.zhang@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06657703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.

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