NCT05952986

A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults

A Randomized, Placebo-Controlled, Double-Blind, Phase I Study to Evaluate the Safety and Bridging Pharmacokinetics Profile of FB825 for Single Subcutaneous Administration in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo-controlled, and double-blind study to evaluate the safety and bridging PK profile of FB825 for single SC administration in healthy adults.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	FB825 or Placebo in subcutaneous route	FB825 or placebo solution for SC injection
DRUG	FB825 in intravenous route	FB825 solution for IV infusion

Timeline

• Start date: 2023-05-03
• Primary completion: 2024-03-26
• Completion: 2024-03-26
• First posted: 2023-07-19
• Last updated: 2024-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study