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

NCT03254810 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2018-11-19

No results posted yet for this study

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.

Conditions

  • Arthritis, Rheumatoid

Interventions

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

Sponsors & Collaborators

  • Synermore Biologics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Niquita Tugiono, MD · Nucleus Network, Center for Clinical Studies Study Site

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2018-07-17
Completion
2018-07-17

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03254810 on ClinicalTrials.gov