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

Guangdong Hengrui Pharmaceutical Co., Ltd1 site in 1 country61 target enrollmentJune 30, 2022

ConditionsIgA Nephropathy

InterventionsSHR-2010 injection SHR-2010 injection placebo

DrugsSHR-2010 injection SHR-2010 injection placebo

Overview

Phase: Phase 1
Intervention: SHR-2010 injection
Conditions: IgA Nephropathy
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment: 61
Locations: 1
Primary Endpoint: Safety and tolerability: Incidence of subjects with adverse events (AEs)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 30, 2022

End Date

March 10, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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/1.73m
•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.
•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.

Arms & Interventions

Treatment for intravenously/subcutaneously

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

Intervention: SHR-2010 injection

Placebo for intravenously/subcutaneously

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

Intervention: SHR-2010 injection placebo

Outcomes

Primary Outcomes

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

Time Frame: Baseline up to Day 85

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.

Secondary Outcomes

Pharmacokinetics (PK) parameter: AUC0-t for SHR-2010(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: t1/2 for SHR-2010(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: AUC0-∞ for SHR-2010(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: CL of SHR-2010 for administration intravenously(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: Cmax for SHR-2010(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: V of SHR-2010 for administration intravenously(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: V/F of SHR-2010 for administration subcutaneously(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: Tmax for SHR-2010(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: CL/F of SHR-2010 for administration subcutaneously(Baseline up to Day 85)
Pharmacodynamics (PD): C4b level in the serum(Baseline up to Day 85)
Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects(Baseline up to Day 85)
Pharmacokinetics (PK) parameter: Bioavailability (F) of SHR-2010(Baseline up to Day 85)