NCT01719874

A Phase 2a, Double-Blind, Placebo-Controlled Study TCN 032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Subjects Challenged With H3N2 Influenza A Virus

Status unknown Phase 2 Last updated 30 October 2012

What this trial tests

Phase 2 trial testing TCN-032 in Influenza in 64 participants. Status unknown.

Timeline

1 August 2012

Primary endpoint
1 December 2012

1 March 2013

Quick facts

Lead sponsor	Theraclone Sciences, Inc.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	1 August 2012
Primary completion	1 December 2012
Estimated completion	1 March 2013
Sites	1 location across United Kingdom

Drugs / interventions tested

• TCN-032 — full drug profile →
• Placebo (saline)

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

Theraclone Sciences, Inc.

Who can join

Adults 18 to 45, any sex, with Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary objective is to evaluate the effect of TCN-032 compared to placebo in the development of clinical signs and symptoms of influenza (including upper respiratory, lower respiratory, systemic and fever).
  Time frame: 7 days

Sponsor's own description

The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy adult volunteers that have been inoculated with the influenza A virus

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of therapeutic antibodies for the treatment of diseases.
   Lu RM, Hwang YC, Liu IJ, Lee CC, et al · · 2020 · cited 1329× · PMID 31894001 · DOI 10.1186/s12929-019-0592-z
2. Universal influenza virus vaccines and therapeutic antibodies.
   Nachbagauer R, Krammer F. · · 2017 · cited 153× · PMID 28216325 · DOI 10.1016/j.cmi.2017.02.009
3. Antibody therapies for the prevention and treatment of viral infections.
   Salazar G, Zhang N, Fu TM, An Z. · · 2017 · cited 138× · PMID 29263875 · DOI 10.1038/s41541-017-0019-3
4. Tackling influenza with broadly neutralizing antibodies.
   Corti D, Cameroni E, Guarino B, Kallewaard NL, et al · · 2017 · cited 111× · PMID 28527859 · DOI 10.1016/j.coviro.2017.03.002
5. Influenza antivirals currently in late-phase clinical trial.
   Koszalka P, Tilmanis D, Hurt AC. · · 2017 · cited 107× · PMID 28146320 · DOI 10.1111/irv.12446
6. Efficacy and safety of treatment with an anti-m2e monoclonal antibody in experimental human influenza.
   Ramos EL, Mitcham JL, Koller TD, Bonavia A, et al · · 2015 · cited 104× · PMID 25281755 · DOI 10.1093/infdis/jiu539
7. M2e-based universal influenza vaccines: a historical overview and new approaches to development.
   Mezhenskaya D, Isakova-Sivak I, Rudenko L. · · 2019 · cited 87× · PMID 31629405 · DOI 10.1186/s12929-019-0572-3
8. Recent advances in therapeutic applications of neutralizing antibodies for virus infections: an overview.
   Ali MG, Zhang Z, Gao Q, Pan M, et al · · 2020 · cited 55× · PMID 33161557 · DOI 10.1007/s12026-020-09159-z