NCT05943886

A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects
• Obesity
• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	HEC88473 injection	HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.
DRUG	Placebo	Placebo will be administered by subcutaneous injection in the abdomen.

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2023-07-13
• Last updated: 2023-07-17

Locations

1 site across 1 country: China