A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide

NCT00964262 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and how the body processes a long-acting form of the diabetes medication exenatide (PT302) in healthy adults after a single injection.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 34 people

Who can join Ages 20–45 · male only Healthy volunteers accepted.

Timeline Started 2009-08 · est. completion 2010-10

Where 1 site · South Korea

What this study is testing ClinicalTrials.gov NCT00964262 ↗

Description as written by the study sponsor.

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.

Treatments tested

SR Exenatide (PT302) Drug

0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection
Placebo Drug

Plcacebo of each doasage, single subcutanoeus injection

Main thing measured	To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
Sponsor	Peptron, Inc.
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00964262 ↗