A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

Dongguan HEC Biopharmaceutical R&D Co., Ltd.1 site in 1 country164 target enrollmentAugust 11, 2021

ConditionsHealthy Subjects Obesity T2DM (Type 2 Diabetes Mellitus)

InterventionsHEC88473 injection Placebo

DrugsHEC88473 injection Placebo

Overview

Phase: Phase 1
Intervention: HEC88473 injection
Conditions: Healthy Subjects
Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Enrollment: 164
Locations: 1
Primary Endpoint: Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (T2DM).

Detailed Description

This study is divided into two parts, Part A is an escalating single-dose study in healthy subjects and obese subjects, and Part B is an escalating multiple-dose study in subjects with T2DM.

Registry

clinicaltrials.gov

Start Date

August 11, 2021

End Date

February 17, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females, between 18 and 45 years of age, inclusive, at screening.
•Body weight ≥ 50 kg for males and body weight ≥ 45 kg for females. 18≤body mass index (BMI)\<28 kg/m2 for nonobese subjects and 28≤BMI≤45 kg/m2 for obese subjects.
•Males or females, between 18 and 65 years of age, inclusive, at screening.
•24 kg/m2≤BMI≤35 kg/m
•Subjects diagnosed with T2DM, newly diagnosed subjects at screening, or treated with diet and exercise alone within 3 months before screening and still have poor blood glucose control, or treated with a stable dose of metformin for ≥ 3 months before screening.
•7.0%≤ HbA1c ≤10.5% at screening.

Exclusion Criteria

•Smoked more than 5 cigarettes per day within 3 months before the study.
•Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to screening or planned vaccination during the course of the study.
•Positive alcohol breath test result or positive urine drug screen.
•Blood donation (\> 300 mL) or massive blood loss (\> 400 mL) within 3 months before screening.
•Have type 1 diabetes mellitus.
•Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
•Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>5 times the upper limit of the reference range at screening.
•Have serum calcitonin ≥20 ng/L at screening.
•Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2; or have hereditary diseases that can easily induce MTC.
•Fasted triglycerides \> 5.7 mmol/L at screening. If the patient is on lipid-lowering therapies, doses must be stable for 30 days prior to screening.