Influenza Antiviral DAS-181-F04 in Healthy Adults

NCT01651494 | Completed Phase 1 FDA Drug

• 2 other identifiers: 12-0009HHSN272201500007I
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

DAS181; Influenza; inhalation; inpatient clinic; Multi-Dose; recombinant neuraminidase

Outcome Measures

Primary Outcomes (1)

• The safety and tolerability of multiple dose DAS181-F04 treatment (measured in adverse events, hematology, clinical chemistry, blood coagulation, haptoglobin, urinalysis, throat swab for bacterial culture, ECG, chest X-ray, and spirometric lung function)

  up to day 90

Secondary Outcomes (2)

• Immunogenicity responses: Blood samples for the immunogenetic profile of DAS181- F04 will be collected

  Day 0, 32, and 90

• Pharmacokinetic profile of DAS181- F04: Cmax, Tmax, Area under the curve (AUC (0-t)), t1/2, AUC (0-infinity), plasma clearance (CL)

  Day 0-4, 6, 9, and 16

Study Arms (2)

DAS181-F04

ACTIVE COMPARATOR

DAS181-F04: 20 mg single-dose each day via inhalation for 3 days; 6 subjects

Drug: DAS181

Placebo

PLACEBO COMPARATOR

Placebo: 20 mg single-dose each day via inhalation for 3 days; 3 subjects

Other: Placebo

Interventions

DAS181 DRUG

DAS181-F04 is a recombinant neuraminidase that is delivered onto the cell surface of the upper and central airway topically and locally through an inhaler as an encapsulated dry powder. DAS181-F04; 20 mg single-dose each day via oral inhalation for 3 days; 6 subjects

DAS181-F04

Placebo OTHER

Placebo: White to off-white powder with Lactose Monohydrate and 5 % moisture; 20 mg single-dose each day via oral inhalation for 3 days; 3 subjects

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Have received any investigational drug or vaccine within 30 days prior to study drug dosing or have had a serious adverse reaction or hypersensitivity to any drug. -Is planning to participate in another clinical trial within 30 days after the last dose of DAS181. -Have received blood products within 6 months of study enrollment. -Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. -Have been on a liquid protein diet in the last month. -Are allergic to lactose. -Have sickle cell disease. -Have used any prescription or nonprescription drugs, excluding hormonal contraception, within 7 days prior to admission unless approved by the site PI or sub-investigator. Subjects must be willing to refrain from taking non-study medication and herbal supplements during the study through Day 32 except those approved by the site PI or sub-investigator. -Existence of any surgical, medical or laboratory condition that, in the judgment of the site PI or sub-investigator, might interfere with the safety, distribution, metabolism, or excretion of the drug. -Subjects with current or a previous history of respiratory diseases (e.g., asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), cystic fibrosis, emphysema, or anaphylaxis) requiring acute or chronic medication, as determined by the investigator through medical history evaluation and physical examination. -Subjects who have experienced a previous episode of acute upper respiratory tract infection, pneumonia, otitis, bronchitis, or sinusitis within 2 weeks prior to screening. -Subjects with concurrent sustained respiratory symptoms (runny nose, sore throat, sneezing, coughing, or wheezing). -Subjects who have an oral temperature above 37.8 degrees C (100 degrees F). -Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic disease, excluding noninvasive basal cell carcinoma. -Subjects who have a planned hospital admission for any cause and/or a planned surgical procedure within 30 days of initiation of the study. -Female subjects who are pregnant or breast-feeding. -Subjects who have donated or lost more than 500mL of blood in the three months prior to screening or who plan to donate blood during study participation. -Subjects who have clinically significant medical or psychological conditions that would compromise the subject's safety, influence the results of the study, affect the subject's ability to participate in the study, or impair the subject's ability to provide informed consent. -Subjects who have a history of drug dependence, or psychiatric illness within 2 years of study enrollment.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Johns Hopkins Bayview Medical Center - Infectious Diseases

Baltimore, Maryland, 21224-2735, United States

Location

Related Publications (1)

• Zenilman JM, Fuchs EJ, Hendrix CW, Radebaugh C, Jurao R, Nayak SU, Hamilton RG, McLeod Griffiss J. Phase 1 clinical trials of DAS181, an inhaled sialidase, in healthy adults. Antiviral Res. 2015 Nov;123:114-9. doi: 10.1016/j.antiviral.2015.09.008. Epub 2015 Sep 25.

  PMID: 26391974 DERIVED

MeSH Terms

Conditions

Influenza, Human; Respiratory Aspiration

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 27, 2012
• Study Start: August 12, 2011
• Primary Completion: September 18, 2012
• Study Completion: September 18, 2012
• Last Updated: April 7, 2017

Record last verified: 2017-04-05

Locations

US (1)