NCT01651494

Influenza Antiviral DAS-181-F04 in Healthy Adults

Completed Phase 1 Last updated 7 April 2017

What this trial tests

Phase 1 trial testing DAS181 in Influenza in 9 participants. Completed in 18 September 2012.

Timeline

12 August 2011

Primary endpoint
18 September 2012

18 September 2012

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	9
Start date	12 August 2011
Primary completion	18 September 2012
Estimated completion	18 September 2012
Sites	1 location across United States

Drugs / interventions tested

• DAS181 — full drug profile →
• Placebo

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be a double-blind, randomized, placebo-controlled study of a single dose (20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the inpatient clinic for the duration of dosing and one day after dosing, they will be required to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and 90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse events and clinical observations.

Publications & conference data

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

1. Overview of Current Therapeutics and Novel Candidates Against Influenza, Respiratory Syncytial Virus, and Middle East Respiratory Syndrome Coronavirus Infections.
   Behzadi MA, Leyva-Grado VH. · · 2019 · cited 78× · PMID 31275265 · DOI 10.3389/fmicb.2019.01327
2. Advances in the development of entry inhibitors for sialic-acid-targeting viruses.
   Heida R, Bhide YC, Gasbarri M, Kocabiyik Ö, et al · · 2021 · cited 39× · PMID 33099021 · DOI 10.1016/j.drudis.2020.10.009
3. 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
4. The current state of research on influenza antiviral drug development: drugs in clinical trial and licensed drugs.
   Li Y, Huo S, Yin Z, Tian Z, et al · · 2023 · cited 20× · PMID 37610204 · DOI 10.1128/mbio.01273-23
5. Retracted and republished from: "The current state of research on influenza antiviral drug development: drugs in clinical trial and licensed drugs".
   Li Y, Huo S, Yin Z, Tian Z, et al · · 2024 · cited 6× · PMID 38551343 · DOI 10.1128/mbio.00175-24
6. Combating Emerging Respiratory Viruses: Lessons and Future Antiviral Strategies.
   Muthukutty P, MacDonald J, Yoo SY. · · 2024 · cited 5× · PMID 39591123 · DOI 10.3390/vaccines12111220