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CompletedNCT05398510Updated Mar 23, 2023

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

A Phase 1 interventional study of SHR-2010 injection and SHR-2010 injection placebo in IgA Nephropathy, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • IgA Nephropathy
03

In context

Glomerulonephritis, IGA

254 studies on the registry are indexed under Glomerulonephritis, IGA; 100 are open to participants now.

This study's enrollment of 61 is below the median of 70 across 206 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Able and willing to provide a written informed consent.
  2. Male or non-pregnant, non-lactating female ages 18 to 55 years old.
  3. Weight ≥ 45 kg, and body mass index (BMI) must range from 18 to 28 kg/m2 .
  4. 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.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Evidence or history of serious cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological, haematological, or metabolic diseases within 5 years.
  2. Subjects with tuberculosis diagnosed by Interferon Gamma Release Assays (IGRA) or chest X-ray.
  3. Subjects had any surgery within the past 6 months before screening or planned to undergo surgery during the study period.
  4. Estimated Glomerular Filtration Rate（eGFR）\<90 mL/min/1.73m2.
  5. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening.
  6. 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.
  7. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) ≥2.0 x ULN, or total bilirubin ≥1.5 x ULN.
  8. Clinically significant abnormal 12-lead ECG at screening (male with QTcF > 450 ms or female with QTcF > 470 ms).
  9. Female subjects who had unprotected sexual behaviour within 14 days before screening.
  10. Positive for alcohol breath test at screening or baseline period.
  11. Positive urinary drug test at screening or baseline period.
  12. Blood collection is difficult or cannot tolerate venipuncture blood collection.
  13. Allergic to any ingredient or component in the study drug.
  14. Subjects who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicine within 14 days prior to using the study drug.
  15. Subjects who smoked more than 5 cigarettes daily in the 1 month before screening.
  16. 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.
  17. Participated in any other clinical trials of any drug or medical device within 3 months before screening.
  18. 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.
  19. Subjects who received live (attenuated) vaccine within 1 month prior to screening or consider getting a vaccination during the study.
  20. The employee of investigator or study centre, with direct involvement in the proposed study.
  21. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Treatment for intravenously/subcutaneously

    Treatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.

    Drug: SHR-2010 injection

  • Placebo comparator
    Placebo for intravenously/subcutaneously

    Treatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.

    Drug: SHR-2010 injection placebo

Interventions

  • DrugSHR-2010 injection

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

  • DrugSHR-2010 injection placebo

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline up to Day 85

Secondary outcomes

  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

    Time frame: 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

    Time frame: Baseline up to Day 85

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

    Cmax: Maximum plasma concentration

    Time frame: Baseline up to Day 85

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

    Tmax: Time to reach maximum plasma concentration

    Time frame: Baseline up to Day 85

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

    t1/2: Terminal half-life

    Time frame: Baseline up to Day 85

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

    CL: Clearance

    Time frame: Baseline up to Day 85

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

    CL/F: Apparent clearance

    Time frame: Baseline up to Day 85

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

    V: Volume of distribution

    Time frame: Baseline up to Day 85

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

    V/F: Apparent volume of distribution

    Time frame: Baseline up to Day 85

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

    Bioavailability of SHR-2010 for administration subcutaneously.

    Time frame: Baseline up to Day 85

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

    C4b level in the serum.

    Time frame: Baseline up to Day 85

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

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

    Time frame: Baseline up to Day 85

07

Study locations

1 site
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266555, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05398510
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Jun 1, 2022
Start date
Jun 30, 2022
Primary completion
Mar 10, 2023
Completion
Mar 10, 2023
Last update
Mar 23, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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