Influenza Antiviral DAS181-F03

NCT01173224 | Completed Phase 1

• 2 other identifiers: 09-0104N01AI80026C
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza (flu) is a common respiratory infection and often causes severe illness. Few drugs are currently approved to treat influenza. This research will test the safety of an experimental anti-influenza drug called DAS181 that is given through an inhaler. The purpose of this study is to evaluate the safety of this new medication and how the body reacts to it. Any side effects will be measured by symptoms, physical examination or laboratory studies. About 27 healthy men and women age 18-45, who meet screening requirements, will participate. Three separate groups will be enrolled, with approximately 9 subjects in each group. Cohort 1:20 mg DAS181 or placebo for 1 day (total dose of 20 mg). Cohort 2: 20 mg DAS181 or placebo for 10 consecutive days (total dose of 200 mg). Cohort 3: 30 mg DAS 181 or placebo for 1 day (total dose of 30 mg.) Procedures include blood samples, electrocardiograms (measures heart activity) and breathing tests.

Conditions

Influenza

Keywords

influenza, DAS181, antiviral

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of single and multiple dose DAS181 treatment: 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)

• Blood samples to determine the pharmacokinetic profile of DAS 181.

  Day 0 through Day 30.

• Blood samples to determine the immunogenic profile of DAS 181.

  Day 0 through Day 90.

Study Arms (3)

Cohort 2: 20 mg 10 days

EXPERIMENTAL

Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg).

Drug: Placebo; Drug: DAS181

Cohort 3: 30 mg 1 day

EXPERIMENTAL

Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg).

Drug: Placebo; Drug: DAS181

Cohort 1: 20 mg, 1 day

EXPERIMENTAL

Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg).

Drug: Placebo; Drug: DAS181

Interventions

Placebo DRUG

Placebo: Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg). Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg). Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg).

Cohort 1: 20 mg, 1 day; Cohort 2: 20 mg 10 days; Cohort 3: 30 mg 1 day

DAS181 DRUG

DAS181 F03: Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg). Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg). Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg).

Cohort 1: 20 mg, 1 day; Cohort 2: 20 mg 10 days; Cohort 3: 30 mg 1 day

Eligibility Criteria

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

You may qualify if:

• Male and female subjects in good health in the opinion of the site Principal Investigator (PI) or subinvestigator as determined by vital signs, medical history, and a physical exam.
• 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 45 years of age (inclusive), at the time of screening.
• Subjects must have a Body Mass Index (BMI) of 18.5-35.
• No recent history of smoking in the past six months regardless of clinical relevance.
• Electrocardiogram (ECG) with no clinically significant abnormalities recorded at screening visit: PR interval within 120 and 200 ms, QRS interval \< 120 ms, and QTc interval less than or equal to 440 ms.
• Blood pressure within normal limits (systolic 90-140 mm Hg; diastolic 50-90 mm Hg) and heart rate between 45 and 100 beats per minute.
• Chest X-ray shows no clinically significant abnormalities.
• Negative Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBSAg), and Hepatitis C Virus (HCV) antibody screening tests.
• Negative screening tests for: marijuana, cocaine metabolite, amphetamines, opiates, Phencyclidine (PCP), barbiturates, benzodiazepines and ethanol.
• Subjects with the following laboratory criteria within provided range:
• Hemoglobin
• White blood cell (WBC) and platelet count
• Alkaline Phosphatase (ALKP), total bilirubin, Alanine Aminotransferase (ALT),
• Serum glucose. Note: If a non-fasting glucose is performed and is abnormal, a fasting glucose measurement may be measured in its place. If this is within the provided range, then subject may be enrolled.

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 or intolerant to lactose.
• Have sickle cell disease.
• Have used any prescription drugs, excluding hormonal contraception, within 7 days prior to admission. Non-prescription drugs or OTC drugs (including herbal supplements) are allowed unless they require intranasal or inhalation administration.
• Existence of any surgical, medical or laboratory condition that, in the judgment of the site PI or subinvestigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
• Subjects with concurrent respiratory diseases (e.g., asthma, allergic rhinitis, chronic obstructive pulmonary disease, 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 Celsius (100 degrees Fahrenheit).
• Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic diseases 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.

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Hospital - Medicine - Infectious Diseases

Baltimore, Maryland, 21287-0005, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

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

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 29, 2010
• First Posted: July 30, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 19, 2013

Record last verified: 2012-11

Locations

US (1)