NCT01747148

Testing the AVI-7100 Flu Drug in Healthy Volunteers

Completed Phase 1 Last updated 26 December 2017

What this trial tests

Phase 1 trial testing AVI-7100 versus placebo in Influenza in 66 participants. Completed in 29 June 2016.

Timeline

8 December 2012

Primary endpoint
29 June 2016

29 June 2016

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Primary purpose	treatment
Enrollment	66
Start date	8 December 2012
Primary completion	29 June 2016
Estimated completion	29 June 2016
Sites	1 location across United States

Drugs / interventions tested

• AVI-7100 versus placebo — full drug profile →

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 60, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Influenza (flu) is a virus that causes people to get sick. Most of the time, the flu causes only a mild illness, but some people can become seriously ill or even die from it. Currently, some pills and inhaled powders can be used to treat the flu, but they only make flu symptoms end about a day sooner. More treatment choices for the flu are needed, especially for those who become seriously ill. Researchers want to test a new drug, AVI-7100, that might keep a person who takes it from having a more serious case of the flu.

Objectives:

\- To see how healthy adult volunteers tolerate the AVI-7100 anti-influenza drug.

Eligibility:

\- Healthy volunteers of normal weight between 18 and 60 years of age.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. A heart function test will also be performed.
* Participants will have either AVI-7100 or a placebo infusion. They will not know which infusion they have. . Participants will stay at the clinical center for a total of 8 hours after the infusion. Blood samples will be collected 1, 2, 4, and 8 hours after the end of the infusion
* Participants will return on Days 1, 2, 4, 10, and 28 after receiving the drug. Blood and urine samples will be collected. A heart function test will also be performed.
* There will be a second part of the study that is separate from the first one. Additional people will receive either AVI-7100 or placebo to test their reactions to a specific dose.

Publications & conference data

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

1. Antiviral combinations for severe influenza.
   Dunning J, Baillie JK, Cao B, Hayden FG, et al · · 2014 · cited 141× · PMID 25213733 · DOI 10.1016/s1473-3099(14)70821-7
2. Innovation and trends in the development and approval of antiviral medicines: 1987-2017 and beyond.
   Chaudhuri S, Symons JA, Deval J. · · 2018 · cited 136× · PMID 29758235 · DOI 10.1016/j.antiviral.2018.05.005
3. RNA interference approaches for treatment of HIV-1 infection.
   Bobbin ML, Burnett JC, Rossi JJ. · · 2015 · cited 61× · PMID 26019725 · DOI 10.1186/s13073-015-0174-y
4. Antiviral strategies against influenza virus: an update on approved and innovative therapeutic approaches.
   Bonomini A, Mercorelli B, Loregian A. · · 2025 · cited 24× · PMID 39945883 · DOI 10.1007/s00018-025-05611-1
5. Safety, tolerability, and pharmacokinetics of radavirsen (AVI-7100), an antisense oligonucleotide targeting influenza a M1/M2 translation.
   Beigel JH, Voell J, Muñoz P, Kumar P, et al · · 2018 · cited 20× · PMID 28929521 · DOI 10.1111/bcp.13405
6. Inhaled siRNA Formulations for Respiratory Diseases: From Basic Research to Clinical Application.
   Fan Y, Yang Z. · · 2022 · cited 10× · PMID 35745766 · DOI 10.3390/pharmaceutics14061193
7. Achieving HIV-1 Control through RNA-Directed Gene Regulation.
   Klemm V, Mitchell J, Cortez-Jugo C, Cavalieri F, et al · · 2016 · cited 8× · PMID 27941595 · DOI 10.3390/genes7120119
8. Update on Influenza.
   Hannaford A, Aleissa M, Sherman AC. · · 2026 · cited 1× · PMID 41135848 · DOI 10.1016/j.amjms.2025.10.010