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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 April 2023
• Main ID: NCT05398510
• Date of registration: 26/05/2022
• Prospective Registration: Yes
• Primary sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
• Public title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject
• Scientific 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
• Date of first enrolment: June 30, 2022
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT05398510
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

China

Key inclusion & exclusion criteria

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:

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: SHR-2010 injection

Drug: SHR-2010 injection placebo

Primary Outcome(s)

Safety and tolerability: Incidence of subjects with adverse events (AEs) [Time Frame: Baseline up to Day 85]

Secondary Outcome(s)

Pharmacokinetics (PK) parameter: AUC0-t for SHR-2010 [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: CL/F of SHR-2010 for administration subcutaneously [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: Cmax for SHR-2010 [Time Frame: Baseline up to Day 85]

Pharmacodynamics (PD): C4b level in the serum [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: V of SHR-2010 for administration intravenously [Time Frame: Baseline up to Day 85]

Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: Bioavailability (F) of SHR-2010 [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: CL of SHR-2010 for administration intravenously [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: Tmax for SHR-2010 [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: AUC0-8 for SHR-2010 [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: V/F of SHR-2010 for administration subcutaneously [Time Frame: Baseline up to Day 85]

Pharmacokinetics (PK) parameter: t1/2 for SHR-2010 [Time Frame: Baseline up to Day 85]

Secondary ID(s)

SHR-2010-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors