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

NCT05398510 | Completed Phase 1

• 1 other identifier: SHR-2010-101
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

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.

  Baseline up to Day 85

Secondary Outcomes (12)

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

  Baseline up to Day 85

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

  Baseline up to Day 85

• Pharmacokinetics (PK) parameter: Cmax for SHR-2010

  Baseline up to Day 85

• Pharmacokinetics (PK) parameter: Tmax for SHR-2010

  Baseline up to Day 85

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

  Baseline up to Day 85

Study Arms (2)

Treatment for intravenously/subcutaneously

EXPERIMENTAL

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

Drug: SHR-2010 injection

Placebo for intravenously/subcutaneously

PLACEBO COMPARATOR

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

Drug: SHR-2010 injection placebo

Interventions

SHR-2010 injection DRUG

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

Treatment for intravenously/subcutaneously

SHR-2010 injection placebo DRUG

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

Placebo for intravenously/subcutaneously

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266555, China

Location

Related Publications (2)

• 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.

  PMID: 40297949 DERIVED

• 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.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-2010 injection compared with placebo

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: June 30, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

CN (1)