NCT05021666

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Placebo	matching placebo
DRUG	PB 718	dose in the next group will be determined following a review of data from the previous group

Timeline

• Start date: 2020-07-29
• Primary completion: 2022-05-18
• Completion: 2022-08-12
• First posted: 2021-08-25
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study