Continuous Multiple Dose PB-119 Injection in Health Volunteers
The Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Continuous Multiple Dose PB-119 Injection in Health Volunteers
Lead sponsor
Asset
Visepegenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
36
Study population
Type 2 diabetes
Eligibility highlights
-
Primary endpoint
•Treatment-Emergent Adverse Events [Safety and Tolerability]
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Male and/or female subjects between the ages of 18~45 years at screening;
2. Weight: female weight of ≥45 kg, male weight of ≥50 kg, subject body mass index (BMI) between 19~30 kg/m2 (inclusive);
3. Pretrial physical examination, blood routine test, urine routine test, liver and kidney function and related laboratory examination results are normal or mildly abnormal but determined by investigator as no clinical significance;
4. Fasting blood glucose (FPG) results of ≤ 6.0mmol / L;
5. Subjects must be consented before study, and willing to sign the written informed consent;
6. Subjects are able to well communicated with investigators, comply with study procedure and complete study.
Exclusion criteria
1. Specific allergy to investigational drug or any ingredients (citric acid, mannitol, m-cresol);
2. Have clinical significant major disease or major surgery within 4 weeks before study initiation.
3. Have any clinical significant major disease history or medical history of circulatory system, endocrine system, nervous system disease or hematology, immunology, psychiatric diseases and metabolic disorders etc.
4. Have history of gastrointestinal, liver and kidney disease (for example: have liver, kidney or gastrointestinal partial resection surgery );
5. Have fever before 3 days of screening;
6. The screening laboratory tests (blood routine test, urine routine test, blood biochemical tests, etc.) were determined by investigator as abnormal with clinical significance within 2 weeks before study initiation;
7. Pretrial electrocardiogram and vital signs were determined as clinically significant abnormal by investigator (systolic blood pressure <90 mmHg or ≥ 140 mmHg, diastolic blood pressure <60 mmHg or ≥ 90 mmHg; heart rate <50 bpm or> 100 bpm);
8. Positive of HIV, hepatitis B surface antigen, hepatitis C, Treponema pallidum antibody test;
9. Alcoholic or frequent drinkers within 6 months before trial, ie more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol contented spirit or 150 mL of wine);
10. Heavily smoker or more than 5 cigarettes per day within 3 months before trial, or any tobacco product used during trial;
11. Drug abusers or those who have used soft drugs (e.g. marijuana) 3 months prior to the trial or those who took hard drugs (e.g. cocaine, phencyclidine, etc.) one year before and during the trial;
12. Allergy to any food or has special requirement to food, not be able to comply to unify diet;
13. Excessive consumption of tea, coffee and / or caffeinated beverages (8 cups or more) per day;
14. Take any medications that may affect test results, such as antibiotics, non-steroidal anti-inflammatory drugs, antacids containing aluminum or magnesium, diuretics, anticoagulants, central nervous system inhibitors, and any drug that may possibly affect the absorption of the drug within 2 weeks before screening;
15. Take any clinical trial investigational medication or participate any drug clinical trial within 3 months before trial;
16. Blood donation up to or more than 360ml within 3 months before screening;
17. Female subjects who plan pregnancy or male subjects who's spouse plan to be pregnant within 6 months;
18. Female subjects who take oral contraceptive within 30 days before and during trial;
19. Female who received long-acting estrogen or progestin injections or implants within 6 months before and during the trial;
20. Female of childbearing potential had non-protective sexual intercourse with partner within 14 days before and during trial;
21. Female who is pregnant or lactating;
22. Subject who cannot complete study due to other reason or determined by investigators as inappropriate to participate this study
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 endpointIncidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame:Change from Baseline lab value at 50 days
event count, event
Other (unclassified)
1 endpointDetermine PB-119 blood concentration
Time frame:Day1-8, Day 15, Day 22, Day 29, Day 36-42, Day 46,Day 50, Day 54 and Day 58
concentration, 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
- PMID33576936via clinicaltrials gov reference derived
Provenance
Sources
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 November 5, 2026 snapshot.