A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-1816 in Healthy Subjects

Beijing Suncadia Pharmaceuticals Co., Ltd1 site in 1 country60 target enrollmentMay 18, 2022

ConditionsDiabetes

InterventionsSHR-1816 Placebo

DrugsSHR-1816 Placebo

Overview

Phase: Phase 1
Intervention: SHR-1816
Conditions: Diabetes
Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Enrollment: 60
Locations: 1
Primary Endpoint: Incidence of hypoglycemic events
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-1816 after single and multiple injection with different dose regimens in healthy subjects.

Registry

clinicaltrials.gov

Start Date

May 18, 2022

End Date

September 5, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and infertility females aged between 18 years and 55 years at screening.
•Male subjects weight ≥50kg, female subjects weight ≥45kg. Body mass index (BMI) in the range of 19-26kg /m
•HbA1c\<6.2% at screening.
•FPG\>3.9mmol/L (70mg/dL) and \<6.1mmol/L (110mg/dL) at screening
•Agree to take effective contraceptive methods.
•Able and willing to provide a written informed consent.

Exclusion Criteria

•The following clinical laboratory tests or examination abnormalities exist during the screening period:
•Any clinically significant lab tests abnormal with one-time retest. 2) ALT and AST were higher than the upper limit of normal value. 3) Subject who has fatty liver disease diagnosed by ultrasound examination. 4) Subject who has abnormal thyroid function. 5) The 12-lead electrocardiogram (ECG) is abnormal and clinically significant, or shows QTcF\>450 ms in male and 470 ms in female.
•Positive infectious diseases screening tests: HBsAg, HCV-Ab, TP-Ig G, HIV-Ab
•Having any of the following diseases or history:
•Subject with a history of hypertension or with abnormal vital signs and clinical significance.
•Subject with a history of life-threatening diseases within the previous 5 years prior to screening.
•Subject with severe systemic infectious diseases within 1 month prior to screening.
•Subject with medical history or family history of medullary thyroid cancer, multiple endocrine adenomatosis type 2, and previous history of pancreatitis.
•Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems.
•Use of any other medicine or other non-drug operations:

Arms & Interventions

Group A

Intervention: SHR-1816

Group B

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of hypoglycemic events

Time Frame: Day1 to Day8/Day29

Incidence of reaction of the injection sites

Time Frame: Day1 to Day8/Day29

Number of adverse Events

Time Frame: Day-2 to Day29/Day50

Secondary Outcomes

Pharmacodynamic (PD) profile of doses of SHR-1816 - fructosamine(Day-1 to Day15/Day29)
Pharmacokinetic (PK) profile of SHR-1816 - AUC0-t(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacokinetic (PK) profile of SHR-1816 - CL/F(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacokinetic (PK) profile of SHR-1816 - MRTinf(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacodynamic (PD) profile of doses of SHR-1816 - C-peptide(Day-1 to Day15/Day29)
Pharmacokinetic (PK) profile of SHR-1816 - Cmax(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacokinetic (PK) profile of SHR-1816 - Vz/F(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacodynamic (PD) profile of doses of SHR-1816 - fasting blood glucose(Day-1 to Day15/Day29)
Pharmacodynamic (PD) profile of doses of SHR-1816 - active GLP-1(Day-1 to Day15/Day29)
Pharmacokinetic (PK) profile of SHR-1816 - AUC0-inf(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacokinetic (PK) profile of SHR-1816 - Tmax(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacokinetic (PK) profile of SHR-1816 - t1/2(pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336 hours post-dose)
Pharmacodynamic (PD) profile of doses of SHR-1816 - insulin(Day-1 to Day15/Day29)
Pharmacodynamic (PD) profile of doses of SHR-1816 - glucagon(Day-1 to Day15/Day29)
Pharmacodynamic (PD) profile of doses of SHR-1816 - total GLP-1(Day-1 to Day15/Day29)
PD profile of multiple doses of SHR-1816 - HbA1c(Day-1, Day29)
PD profile of multiple doses of SHR-1816 - weight(Day-1 to Day15/Day29)
Immunogenicity(Day1 to Day29/Day50)
PD profile of multiple doses of SHR-1816 - 7-points glucose profile(Day-1 to Day15/Day29)