Study S002032

An Open-label Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics of Single-dose of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

ClinicalTrials.gov record

Registration

Registration: NCT05328843
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: UNKNOWN
Enrollment: 24
Start: 2022-05-01
Primary completion: 2022-10-01
Lead sponsor: PegBio Co., Ltd.
Conditions: Type2Diabetes
Interventions: DRUG:PB119
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

Primary PK parameters: AUC0-inf [Up to 336 h(Day15) post-dose]
Primary PK parameters: AUC0-t [Up to 336 h(Day15) post-dose]
Primary PK parameters: Cmax [Up to 336 h(Day15) post-dose]

Linked records (0)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

No records link to this registration yet.