Study S003293

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PB-718 Following Subcutaneous Administration in Healthy Subjects

ClinicalTrials.gov record

Registration

Registration: NCT05021666
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: TRIPLE
Status: COMPLETED
Enrollment: 82
Start: 2020-07-29
Primary completion: 2022-05-18
Lead sponsor: PegBio Co., Ltd.
Conditions: Healthy Subjects
Interventions: DRUG:Placebo; DRUG:PB 718
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks.]

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