№ files_lp_3_process_9_72959
Participant handbook for a Phase 1 clinical trial describing the background, design, investigational plasmid therapy, eligibility criteria, procedures, and organizational framework of the TN-27 TOPPLE T1D study within the TrialNet research network.
Date: 22JAN2021
Version: 3.0
Protocol Number: TN-27
Study Name: TOPPLE T1D Study – Tolerance Using Plasmid T1D
Phase: Phase 1
Study Design: Multiple ascending dose trial
Investigational Product: NNC0361-0041
Condition: Type 1 diabetes mellitus
Sponsor Collaboration: Novo Nordisk
Research Network: Type 1 Diabetes TrialNet
Supporting Institutions: National Institutes of Health; National Institute of Diabetes and Digestive and Kidney Diseases
Study Site: Stanford University
Research Physician: Darrell Wilson, MD
Target Population: Adults diagnosed with type 1 diabetes within the previous 48 months
Planned Enrollment: Approximately 48 participants
Geographic Scope: United States, Canada, Europe, Australia
Therapeutic Approach: Plasmid-based immunotherapy administered subcutaneously
Price: 8 / 10 USD
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