Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza

NCT01740063 | Completed Phase 2 DMC

• 1 other identifier: DAS181-2-04
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza virus (IFV). Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a placebo group. The modified intent to treat (mITT) analysis set will include subjects with confirmed influenza as documented by qPCR or TCID50. The full analysis set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Per protocol, the safety analysis sets are described below in statistical methods. A subpopulation of 60 participants will also have additional PK and Immunogenicity blood samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all study visits.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Number of participants with Unacceptable Serious Adverse Events due to safety and toxicity Safety and toxicity profile: Unacceptable Serious Adverse Events Safety and toxicity profile: Unacceptable Serious Adverse Events

  Because of the possibility of unacceptable or excessive defined serious adverse events during the treatment period or the study enrollment period, a stopping rule for safety/tolerability has been introduced in the design. The following two stopping rule criteria will initiate an ad hoc DSMB data evaluation. * 5% with a related SAE post-dose Day 1 through Day 28 , or * 15% with related DAIDS toxicity Grade 3 and 4 laboratory abnormalities post-dose Day 1 through Day 28 * Grade 3 laboratory abnormalities in hematology or serum chemistry, excluding absolute neutrophils and absolute lymphocytes. * Grade 4 laboratory abnormalities in hematology or serum chemistry including absolute neutrophils and absolute lymphocytes Changes (absolute and percent) from baseline in influenza viral load from Day 1 to Day 2 as measured by quantitative polymerase chain reaction (qPCR) from pharyngeal wash and nasal wash samples.

  Participants will be followed (up to one year) for the duration of the study and outcome measure will be reviewed at the end of study. The expected end of study is Sept. 2013.

Study Arms (3)

DAS181-F02 formulation

EXPERIMENTAL

DAS181 10 mg dose for three days of the F02 formulation

Drug: DAS181-F02 formulation

DAS181-F04 formulation

EXPERIMENTAL

DAS181 20 mg dose group for three days of the F04 formulation,

Drug: DAS181-F04 formulation

Placebo

PLACEBO COMPARATOR

placebo group

Drug: Placebo

Interventions

DAS181-F02 formulation DRUG

DAS181-F02 formulation

DAS181-F04 formulation DRUG

DAS181-F04 formulation

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a physical exam based on medical history.
• Subjects must be able to verbalize understanding of the consent form, provide written informed consent and verbalize willingness to complete study procedures.
• Be 18 to 70 years of age (inclusive).
• Subjects must weigh at least 50 kg and must have a Body Mass Index (BMI) of no greater than 40.00.
• Febrile, oral temperature ≥100.4°F (≥38.0°C) in combination with symptoms
• At least one respiratory symptom:
• Cough
• Sore throat
• Wheezing
• Sneezing
• Shortness of breath
• Nasal congestion
• Earache
• Pleuritic chest pain
• At least one constitutional symptom:

You may not qualify if:

• Have received any investigational drug or investigational vaccine within 8 weeks prior to study drug dosing.
• Have had a serious adverse reaction or previous episode of anaphylaxis related to any drug.
• Have received blood products within 6 months of study enrollment.
• Have concurrent cystic fibrosis or emphysema.
• Have sickle cell disease.
• Known IGE mediated allergic response to lactose (not lactose intolerance).
• Any history of congenital or acquired bleeding abnormalities.
• Existence of any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
• Use of antiviral influenza medications within 10 days prior to screening (Subjects will be prohibited from taking antiviral influenza medications during the course of the trial).
• Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening.
• Known hypersensitivity to DAS181.
• Women who are pregnant (urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding.
• Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study participation.
• Any significant findings in the subject's medical history or physical examination that, in the opinion of the investigator, would affect subject safety or compliance with the dosing schedule.
• Subjects with history of asthma or chronic obstructive pulmonary disease (COPD) requiring the use of acute or chronic medication in the past 3 years.

Sponsors & Collaborators

• Ansun Biopharma, Inc.: lead

Study Sites (1)

Nexbio

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

US (1)