Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT05398510
Start Date
June 30 2022
End Date
March 10 2023
Last Update
March 23 2023
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266555