BIVV009‐01: SAFETY, TOLERABILITY AND ACTIVITY OF TNT009
Research type
Research Study
Full title
SAFETY, TOLERABILITY AND ACTIVITY OF BIVV009‐01 IN HEALTHY VOLUNTEERS AND PATIENTS WITH COMPLEMENT-MEDIATED DISORDERS. A SINGLE/MULTIPLE ASCENDING DOSE PHASE 1 STUDY -PART E
IRAS ID
233951
Contact name
William Townsend
Contact email
Sponsor organisation
True North Therapeutics, Inc.
Eudract number
2014-003881-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Study BIVV009‐01- PART E, is a long-term safety extension arm following on from the TNT009-01 study. The BIVV009‐01 Study was a First in Human (FIH) study that used an Integrated Protocol Design. This Phase 1 study protocol comprised 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 suffering from orphan diseases that are complement-mediated disorders. The original study part A, B, and C was submitted, approved and performed in Austria only.
BIVV009‐01- PART E is being submitted as an addition to the original protocol to allow patients suffering from Cold agglutinin disease (CAD) that demonstrated a positive response in Part C of the study or as part of a named patient program to continue to receive BIVV009‐01 and be followed for safety and efficacy under protocol.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0370
Date of REC Opinion
6 Nov 2017
REC opinion
Further Information Favourable Opinion