A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects

Shandong Suncadia Medicine Co., Ltd.0 sites106 target enrollmentMay 1, 2022

ConditionsHealthy Subjects

InterventionsHRS-7535 Placebo

DrugsHRS-7535 Placebo

Overview

Phase: Phase 1
Intervention: HRS-7535
Conditions: Healthy Subjects
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Enrollment: 106
Primary Endpoint: Number of adverse Events
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS-7535 in healthy subjects.

Registry

clinicaltrials.gov

Start Date

May 1, 2022

End Date

March 15, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must be 18 to 55 years of age (inclusive) healthy male or female of nonchildbearing potential;
•Body weight of at least 50 kg for male, and 45 kg for female; and Body Mass Index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
•Subjects (including partners) of childbearing potential are willing to use protocol specified effective methods of contraception from screening to at least 6 months after the final dose of study drug;
•Able and willing to provide written informed consent and to comply with the study protocol;
•Physical examination, vital signs are normal or are judged not clinically significant by the investigator;

Exclusion Criteria

•Participants with any abnormal results and judged clinically significant by the investigator;
•HbA1c ≥6.2%, fasting blood-glucose ≤3.9mmol/L (70mg/dL) or ≥6.1mmol/L(110mg/dL) at screening ;
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN; total bilirubin ≥1.5 x ULN at screening;
•Abnormal ECG that is clinically significant, or QTcF \>450 msec;
•Positive test result of any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C antibody, syphilis, or human immunodeficiency virus (HIV) antibody;
•Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years;
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, history of pancreatitis or symptomatic gallbladder disease;
•History of gastric emptying anomalies (gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer) ;
•Subject with major medical history of heart, liver, kidney, endocrine, digestive, blood, respiratory and genitourinary system or existing diseases of the above systems;
•Use any prescription drugs, non-prescription drugs, food supplements, vitamins and Chinese herbal medicines within 2 weeks before administration;

Arms & Interventions

Group A

Drug: HRS-7535

Intervention: HRS-7535

Group B

Drug: Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of adverse Events

Time Frame: Day-2 to last follow-up

Number of adverse events per subject, including clinically relevant changes in physical examination, vital signs, laboratory tests and ECGs;

Secondary Outcomes

Pharmacokinetic (PK) profile of HRS-7535 - CL/F(pre-dose to 96 hours post-dose)
Pharmacokinetic (PK) profile of HRS-7535 - t1/2(pre-dose to 96 hours post-dose)
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t(pre-dose to 96 hours post-dose)
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞(pre-dose to 96 hours post-dose)
Pharmacokinetic (PK) profile of HRS-7535 - Cmax(pre-dose to 96 hours post-dose)
Pharmacokinetic (PK) profile of HRS-7535 - Tmax(pre-dose to 96 hours post-dose)
PD profile of multiple doses of HRS-7535 - 5-points glucose profile(pre-dose up to 24 hours after the last dose)
Pharmacokinetic (PK) profile of HRS-7535 - Vz/F(pre-dose to 96 hours post-dose)
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-τ,ss(pre-last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-t,ss(pre- last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - AUC0-∞,ss(pre- last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - Tmax,ss(pre- last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - Cmax,ss(pre- last doseto 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - Ctrough,ss(pre- last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - Vz,ss/F(pre- last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - t1/2,ss(pre- last dose to 96 hours post- last dose)
Pharmacodynamic (PD) profile of doses of HRS-7535 - blood glucose(pre-dose to 24 hours post-dose)
Pharmacodynamic (PD) profile of doses of HRS-7535 - insulin(pre-dose to 24 hours post-dose)
Pharmacodynamic (PD) profile of doses of HRS-7535 - C-peptide(pre-dose to 24 hours post-dose)
Pharmacodynamic (PD) profile of doses of HRS-7535 - glucagon(pre-dose to 24 hours post-dose)
Pharmacokinetic (PK) profile of HRS-7535 - Cavg,ss(pre- last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - DF(pre- last dose to 96 hours post- last dose)
Pharmacokinetic (PK) profile of HRS-7535 - CLss/F(pre- last dose to 96 hours post- last dose)
PD profile of multiple doses of HRS-7535 - HbA1c(pre-dose up to 96 hours after the last dose)
Pharmacodynamic (PD) profile of doses of HRS-7535 - fructosamine(pre-dose up to 96 hours after the last dose)
PD profile of multiple doses of HRS-7535 - weight(pre-dose up to 96 hours after the last dose)