NCT03188848

Dose Escalating Study of BPI-3016 in Healthy Subjects

A Randomized, Double-blind, Placebo Controlled, Dose Finding Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BPI-3016 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, dose finding study evaluating the safety, pharmacokinetics and pharmacodynamics of subcutaneously injected BPI-3016 in Chinese healthy subjects.

Detailed description

BPI-3016 is a novel analogue of glucagon-like peptide-1 (GLP-1) that developed for the treatment of type 2 diabetes mellitus. This is a randomized, double-blind, placebo-controlled, dose finding study evaluating the safety, pharmacokinetics and pharmacodynamics of subcutaneously injected BPI-3016 in Chinese healthy subjects.

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	BPI-3016	Single-dose subcutaneous injection of BPI-3016
DRUG	Placebo	Single-dose subcutaneous injection of placebo to match BPI-3016

Timeline

• Start date: 2017-05-24
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2017-06-15
• Last updated: 2019-01-02

Locations

1 site across 1 country: China