Last updated on January 2019

Safety Tolerability and Activity of TNT009 in Healthy Volunteers and Patients With Complement Mediated Disorders

Brief description of study

Prospective, double-blind, randomized, placebo-controlled First-In-Human study with three sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in NHVs, Part C, a multiple dose (MD) study in patients with a complement-mediated disorder.

Detailed Study Description

Study TNT009-01 is a First in Human (FIH) study that uses an Integrated Protocol Design. This Phase 1 study protocol will comprise three sub-parts: a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study in normal male and female human volunteers (NHVs), and a Multiple Dose (MD) study in patients with various complement-mediated disorders not confined to a single disease or therapeutic area. Although these patients represent a population with a diverse set of clinical diagnoses they are united by a common mechanism of disease matched to the mechanism of action of TNT009. Several key safety measures have been incorporated into the design of this study, including use of Sentinel Dosing Groups and an independent Data Safety Monitoring Board (DSMB), as well as an appropriate program of prophylactic vaccinations and clinical biomarker surveillance related to the risks potentially associated with inhibition of the complement system.

Clinical Study Identifier: NCT02502903

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Sabine Schranz

Medical University of Vienna
Vienna, Austria
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Recruitment Status: Open

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