NCT03254810

Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects

A Phase 1 Randomized Blinded Single Dose Comparison of the Safety and Pharmacokinetics of SYN060 Compared to Adalimumab (Humira®) From North American and European Sources in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Synermore Biologics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study.

Detailed description

This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study. A total of 90 subjects will be randomized in a 1:1:1 ratio to from a centrally generated randomization schedule to SYN060 or adalimumab of American or European sources resulting in 30 subjects in each group.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	SYN060	a single subcutaneous 0.57 mg/kg dose of SYN060
BIOLOGICAL	Adalimumab North American source	a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source
BIOLOGICAL	Adalimumab European source	a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source

Timeline

• Start date: 2017-09-26
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2017-08-21
• Last updated: 2018-11-19

Locations

1 site across 1 country: Australia