A Phase I Clinical Study on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2106 After a Single Intravenous or Subcutaneous Administration of SHR-2106 in Healthy Subjects

Guangdong Hengrui Pharmaceutical Co., Ltd1 site in 1 country58 target enrollmentJuly 11, 2023

ConditionsKidney Transplantation

InterventionsSHR-2106 injection or placebo

DrugsSHR-2106 injection or placebo

Overview

Phase: Phase 1
Intervention: SHR-2106 injection or placebo
Conditions: Kidney Transplantation
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment: 58
Locations: 1
Primary Endpoint: Assess the incidence and severity of adverse events in healthy subjects after single dose of SHR-2106 injection
Status: Enrolling by Invitation
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study with the primary objective of evaluating the safety and tolerability of SHR-2106 in healthy subjects after a single intravenous or subcutaneous administration.

Registry

clinicaltrials.gov

Start Date

July 11, 2023

End Date

June 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Obtain informed consent prior to the commencement of any activities related to the trial, have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
•Age 18 \~ 55 years old (including boundary value), male or female;
•Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) = weight (kg) / height 2 (m2), BMI in the range of 19 \~ 28 kg/m2 (including boundary value);
•Random pre-physical examination, vital signs, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), thyroid function, chest radiograph, 12-lead ECG results are normal or abnormal and have no clinical significance;
•Subjects and their partners who have no fertility plan and voluntarily take highly effective contraception during the study period to the last follow-up of the trial (the last follow-up time between dose groups is shown in Table 9), 6 months (female subjects receiving SHR-2106) or 3 months (male subjects receiving SHR-2106) and voluntarily take highly effective contraception (see Annex 1 of the protocol for specific contraceptive measures), female subjects must have a negative serum pregnancy test and be non-lactating.

Exclusion Criteria

•The subject's medical history, symptoms and examination results at the time of screening suggest active tuberculosis or latent tuberculosis. All participants will be screened for TB status by γ interferon gamma release assay (IGRA) and chest radiograph (x-ray). Participants who underwent IGRA and x-ray examination within 1 month prior to screening may, at the discretion of the investigator, not repeat IGRA and x-ray at screening;
•History of severe cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic and other diseases (within 5 years);
•Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
•Those who have chronic infection or recurrent infection within 12 months before screening and need treatment;
•Those who donated blood or lost a total of ≥200 mL within 1 month before screening or administration, or ≥ 400 mL of blood donation or blood loss within 3 months before administration, or who received blood transfusion within 2 months;
•Those who have a history of allergies to two or more foods and drugs; or a known history of allergy to the study drug or any component of the study drug (see Annex 2 of the protocol for injectable ingredients);
•History of tobacco addiction within 3 months before screening, defined as: an average of more than 5 cigarettes smoked per day; or those who are unable to comply with the no-smoking requirements during the study;
•Alcoholics within 3 months before screening (1 day intake of alcohol more than 15 g for women, more than 25 g for men \[5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine or about 17 mL of low-alcohol liquor\], more than 2 times a week) or positive alcohol breath test at baseline;
•Systolic blood pressure (SBP) before screening or administration: SBP ≥ 140 mmHg or \< 90 mmHg; diastolic blood pressure (DBP) :D BP≥ 90 mmHg or \< 50 mmHg;
•Glutaminase (AST) or alanine aminotransferase (ALT) at screening≥ 2 times the upper limit of normal range (ULN), or total bilirubin ≥ 1.5 times ULN

Arms & Interventions

Part 1: SHR-2106 injection or placebo single dose, iv

Intervention: SHR-2106 injection or placebo

Part 2: SHR-2106 injection or placebo single dose, sc

Intervention: SHR-2106 injection or placebo

Outcomes

Primary Outcomes

Assess the incidence and severity of adverse events in healthy subjects after single dose of SHR-2106 injection

Time Frame: About 6 months from the first medication to the evaluation

Secondary Outcomes

Assess the concentration of SHR-2106 in plasma(About 6 months after the first dose)
To assess incidence of ADA following a single intravenous of SHR-2106 in healthy subjects(About 6 months after the first dose)
Evaluation of AUC0-t of SHR-2106 in plasma(About 6 months after the first dose)
Evaluation of t1/2 of SHR-2106 in plasma(About 6 months after the first dose)
Evaluation of Cmax of SHR-2106 in plasma(About 6 months after the first dose)
Evaluation of AUC0-∞ of SHR-2106 in plasma(About 6 months after the first dose)
Evaluation of Tmax of SHR-2106 in plasma(About 6 months after the first dose)