CompletedPhase 1

Clinical Trial for PB-119 in Healthy Subjects (Phase I)

Safety, Tolerability and Pharmacokinetics of Single Dose of PB-119 in Healthy Volunteers

Lead sponsor

PegBio Co., Ltd.

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 19-24

Primary endpoint

•Safety/Adverse Event Outcome Measure

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 IDNCT02084251

Org study IDICP-I-2013-08

Timeline

Milestones

Study first posted2014-03-11estimated

Last update posted2017-02-14actual

Study start2014-02 (month precision)

Primary completion2014-11actual (month precision)

Study completion2014-11actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female volunteers, ages: between 18-45;

•Body weight： female >= 45kg, male >=50kg, BMI >=19-24kg/m2

•Physical examination, blood routine, urine routine, liver and kidney function and related laboratory tests are normal or slightly abnormal but not clinically significant;

•Read, agree, and sign the informed consent;

•Be able to communicate with the investigator and finish the study according to the protocol.

Exclusion criteria

（anyone or more of the following):

•Allergic to the API or excipients used (citric acid, mannitol, Meta-Cresol);

•Experiencing clinically significant disease or surgery within 4 weeks before the study;

•Clinically significant disease history in systems including cardiovascular system, endocrine system, neutral system, immunology system, psychiatry，metabolic disorder;

•Disease history of gastrointestinal tract, liver, and kidney (for example, the Partial resection surgery in GI tract, liver, or kidney);

•Fever history within 3 days of the screening;

•Clinical significant abnormality found in laboratory tests (blood, urine routine test) within 2 weeks before study;

•ECG or vital signs is clinically significant abnormality as judged by the Investigator( systolic blood pressure <90mmHg or ≥140mmHg; diastolic blood pressure<60mmHg or ≥90mmHg; heart rate <50bpm or >100bpm);

•Antibody test for HIV, BsAg, C hepatitis, or Microspironema pallidum positive;

•Alcoholics or drink frequently within 6 months of trial (more than 14 unit of alcohol, in which 1 unit is 360mL beers, or 45 ml wine with 40% alcohol content, or 150mL port wine;

•Addicted to cigarette, tea, coffee or drugs;

•Have specific requirement for diets (or allergic to any food);

•Have been administered in the past 2 weeks with any drug (such as antibiotics, anticoagulant, diuretics) that might interfere the PK profile of drug/drug candidate to be used in this study;

•Participated in any clinical trial in the past 3 months;

•Donated blood of more than 360 ml in the past 3 months;

•Plan to be pregnant herself or his spouse in the next 6 months;

•Females administered with any oral contraceptive 30 days before the study or during the study;

•Females dosed with long acting estrogen or progestin (injections or implant) 6 months before the study or during the study;

•Females at childbearing age that had unprotected intercourse 14 days before the study or will have during the study;

•Female who is pregnant or nursing;

•Anybody who might not be able to complete the study, or considered not appropriate by the investigator.

Endpoints (1)

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

1 endpoint

Primary/protocol endpoint

Safety/Adverse Event Outcome Measure

Time frame:Up to 3 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

Safety, Tolerability and Pharmacokinetics of Single Dose Polyethylene Glycolated Exenatide Injection (PB-119) in Healthy Volunteers.
European journal of drug metabolism and pharmacokinetics2020 Jun (month)PMID32006325doi:10.1007/s13318-020-00605-9via clinicaltrials gov reference derived + pubmed nct search

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.