SR-Exenatide

CompletedPhase 1

Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects

A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•Male•Healthy volunteers

Primary endpoint

•Assessment of safety

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01156779

Org study IDDA3091_DM_I

Timeline

Milestones

Study first posted2010-07-05estimated

Last update posted2013-08-13estimated

Study start2010-07 (month precision)

Primary completion2012-04actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age20 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

1. Age : 20 ~ 45 years old

2. Healthy Male

3. Body weight : ≥50kg and Ideal body weight ± 20%

4. Informed consent

Exclusion criteria

1. Clinically significant medical history

2. Acute or Chronic pancreatitis

3. Clinically significant hypersensitivity of Drugs

4. Clinically significant cutaneous disorder

5. History of administration of exenatide

6. Disorder of blood pressure

7. History of drug abuse

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Assessment of safety

Time frame:84 days

descriptive

Secondary/protocol endpoint

Pharmacokinetics and Pharmacodynamics

Time frame:PK : 84 days / PD : 42days

descriptive

Publications (2)

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

Pharmacokinetics of Exenatide in nonhuman primates following its administration in the form of sustained-release PT320 and Bydureon.
Scientific reports2019 Nov 20PMID31748513doi:10.1038/s41598-019-53356-2via pubmed acronym asset candidate
Pharmacokinetics and efficacy of PT302, a sustained-release Exenatide formulation, in a murine model of mild traumatic brain injury.
Neurobiology of disease2019 Apr (month)PMID30471415doi:10.1016/j.nbd.2018.11.023via pubmed acronym asset candidate

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.