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CompletedPhase 1

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

A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of SR Exenatide (PT302) After Subcutaneous Injection in Healthy Male Volunteers

Lead sponsor

Peptron, Inc.

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

34

Study population

Healthy volunteers

Eligibility highlights

•Male•Healthy volunteers

Primary endpoint

•Safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00964262
Org study IDPepE01

Timeline

Milestones

Study first posted2009-08-24estimated
Last update posted2013-07-19estimated
Study start2009-08 (month precision)
Primary completion2010-10actual (month precision)
Study completion2010-10actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age20 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Healthy male subjects aged 20-45 years at screening
•Body weight over 50 kg, inclusive, and within 20% of ideal body weight

Exclusion criteria

•Has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
•Has a sign or symptom or history related to an acute or chronic pancreatitis
•Has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
•Has ever been exposed to exenatide
•Shows SBP >= 150 mmHg or <= 90 mmHg or DBP >= 100 mmHg or <= 50 mmHg
•Has a presence or history of drug abuse
•Uses any prescription drug, herbal medicine within 2 weeks or OTC drugs or vitamin within 1 week prior to study drug administration
•Has been participated in other clinical trial within 2 months
•Has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
•Heavy smoker more than 10 cigarettes/day within 3 months prior to screening
•Continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
•Subjects not eligible at the discretion of investigators

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection

Time frame:8 weeks

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection

Time frame:8 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.