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IgA NephropathyPhase 1NCT05398510

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject

A Phase 1 study testing SHR-2010 injection in people with IgA Nephropathy, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
IgA Nephropathy
What is being tested?
SHR-2010 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteChina
Study dates
30 Jun 2022to 10 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Able and willing to provide a written informed consent.
  • Male or non-pregnant, non-lactating female ages 18 to 55 years old.
  • Weight ≥ 45 kg, and body mass index (BMI) must range from 18 to 28 kg/m2 .
  • Healthy subjects as determined by absence of clinically significant abnormalities on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests performed at screening or baseline period.
  • Subjects must be willing to use a highly effective method of contraception as deemed appropriate by the investigator throughout the study and for at least 3 months after the last study drug administration.

Who cannot join

  • Evidence or history of serious cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological, haematological, or metabolic diseases within 5 years.
  • Subjects with tuberculosis diagnosed by Interferon Gamma Release Assays (IGRA) or chest X-ray.
  • Subjects had any surgery within the past 6 months before screening or planned to undergo surgery during the study period.
  • Estimated Glomerular Filtration Rate（eGFR）<90 mL/min/1.73m2.
  • Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening.
  • Systolic blood pressure (SBP) > 140 mm Hg or < 90 mm Hg, or diastolic blood pressure (DBP) > 90 mm Hg or < 60 mm Hg and has been considered clinically significant.
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  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) ≥2.0 x ULN, or total bilirubin ≥1.5 x ULN.
  • Clinically significant abnormal 12-lead ECG at screening (male with QTcF > 450 ms or female with QTcF > 470 ms).
  • Female subjects who had unprotected sexual behaviour within 14 days before screening.
  • Positive for alcohol breath test at screening or baseline period.
  • Positive urinary drug test at screening or baseline period.
  • Blood collection is difficult or cannot tolerate venipuncture blood collection.
  • Allergic to any ingredient or component in the study drug.
  • Subjects who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicine within 14 days prior to using the study drug.
  • Subjects who smoked more than 5 cigarettes daily in the 1 month before screening.
  • History of regular alcohol consumption exceeding 3 units/day for women or 5 units/day for men, more than twice per week (1 unit = 150 ml of beer or 50 ml of wine or 17 ml of alcoholic spirits) within 3 months before screening.
  • Participated in any other clinical trials of any drug or medical device within 3 months before screening.
  • Donated blood or blood products or had substantial loss of blood (more than 400 mL) within 1 month before screening, or received any blood or blood products within 2 months prior to screening.
  • Subjects who received live (attenuated) vaccine within 1 month prior to screening or consider getting a vaccination during the study.
  • The employee of investigator or study centre, with direct involvement in the proposed study.
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266555

Other trials in China

About this study

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous/Subcutaneous Injection of SHR-2010 in Healthy Subjects: a Randomized, Double-blind, Dose-increasing, Placebo-controlled Phase I Clinical Trial

The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.

Conditions
IgA Nephropathy
Being tested
SHR-2010 injection, SHR-2010 injection placebo
Medical subject headings
Glomerulonephritis, IGA

What participants receive

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

  • SHR-2010 injectionDrug

    Treatment for intravenously: 6 subjects for SR-2010 injection. Treatment for subcutaneously: 8 subjects for SR-2010 injection.

  • SHR-2010 injection placeboDrug

    Treatment for intravenously: 2 subjects for placebo. Treatment for subcutaneously: 2 subjects for placebo.

Study groups in NCT05398510
Study groupRoleWhat they receive
Treatment for intravenously/subcutaneouslyExperimentalTreatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.
Receives: Drug: SHR-2010 injection
Placebo for intravenously/subcutaneouslyPlacebo comparatorTreatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.
Receives: Drug: SHR-2010 injection placebo

What is being measured

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

  1. Safety and tolerability: Incidence of subjects with adverse events (AEs)

    Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation and/or IGRA.

    Measured: Baseline up to Day 85

Secondary outcomes (12)

  1. Pharmacokinetics (PK) parameter: AUC0-t for SHR-2010

    AUC0-t: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration

    Measured: Baseline up to Day 85

  2. Pharmacokinetics (PK) parameter: AUC0-∞ for SHR-2010

    AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity

    Measured: Baseline up to Day 85

  3. Pharmacokinetics (PK) parameter: Cmax for SHR-2010

    Cmax: Maximum plasma concentration

    Measured: Baseline up to Day 85

  4. Pharmacokinetics (PK) parameter: Tmax for SHR-2010

    Tmax: Time to reach maximum plasma concentration

    Measured: Baseline up to Day 85

  5. Pharmacokinetics (PK) parameter: t1/2 for SHR-2010

    t1/2: Terminal half-life

    Measured: Baseline up to Day 85

  6. Pharmacokinetics (PK) parameter: CL of SHR-2010 for administration intravenously

    CL: Clearance

    Measured: Baseline up to Day 85

  7. Pharmacokinetics (PK) parameter: CL/F of SHR-2010 for administration subcutaneously

    CL/F: Apparent clearance

    Measured: Baseline up to Day 85

  8. Pharmacokinetics (PK) parameter: V of SHR-2010 for administration intravenously

    V: Volume of distribution

    Measured: Baseline up to Day 85

  9. Pharmacokinetics (PK) parameter: V/F of SHR-2010 for administration subcutaneously

    V/F: Apparent volume of distribution

    Measured: Baseline up to Day 85

  10. Pharmacokinetics (PK) parameter: Bioavailability (F) of SHR-2010

    Bioavailability of SHR-2010 for administration subcutaneously.

    Measured: Baseline up to Day 85

  11. Pharmacodynamics (PD): C4b level in the serum

    C4b level in the serum.

    Measured: Baseline up to Day 85

  12. Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects

    Proportion of anti-drug antibodies (ADA) positive subjects.

    Measured: Baseline up to Day 85

Timeline

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

  1. First posted1 Jun 2022
  2. Study start30 Jun 2022
  3. Primary completion10 Mar 2023
  4. Study completion10 Mar 2023

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
Model description
SHR-2010 injection compared with placebo
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398510
Sponsor's protocol ID
SHR-2010-101
Status last verified
Mar 2023
First submitted
26 May 2022
Last updated
23 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lin P, Wang C, Hu X, Fang L, Lin H, Sun F, Huang R, Ban R, Feng S, Gao Z, Shen K, Cao Y. Safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-2010, a novel anti-MASP-2 antibody, in healthy volunteers: a randomized, double-blind, placebo-controlled phase 1 study. Expert Opin Investig Drugs. 2025 Apr;34(4):339-348. doi: 10.1080/13543784.2025.2500291. Epub 2025 May 1.

    PubMed 40297949

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PubMed 38299639

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-2010 injection in people with IgA Nephropathy, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site 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 21 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: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability: Incidence of subjects with adverse events (AEs) (time frame: Baseline up to Day 85). 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 NCT05398510, which also lists 2 linked publications.

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 23 Mar 2023.

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