InfluenzaPhase 1NCT01173224
Influenza Antiviral DAS181-F03
A Phase 1 study testing DAS181 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- DAS181
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- Peak Expiratory Flow Rate (PEFR) will be greater than 80 percent predicted and Forced Expiratory Volume in One Second (FEV1) will be greater than 80 percent predicted. Note: Only one baseline value for PEFR and FEV1 can be used to support inclusion criterion.
- 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.
- Serum creatinine
- Activated partial thromboplastin time (APTT) and Fibrinogen
- Urine glucose and blood tested by dipstick urinalysis are negative. Urine protein tested by dipstick is negative or trace. Menstruating females failing inclusion due to positive urine dipstick blood may be retested following cessation of menses.
- Female subjects must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or agreeable to practicing abstinence or two effective methods of birth control during the study period and for 12 weeks after study product administration. Acceptable methods may include:
- intrauterine device
- spermicide
- barrier contraception
- hormonal contraception.
- A female subject must have had a negative serum pregnancy test during the screening visit and a negative urine pregnancy test within 24 hours of drug dosing.
- If male, agrees to use medically accepted form of contraception from time of enrollment to 12 weeks after study product administration.
- Agrees not to drink any products containing caffeine (e.g., coffee, tea, soda) for 24 hours before the inpatient visit and during the entire inpatient admission.
- Agrees not to drink alcohol or participate in strenuous physical activity or exercise from 24 hours prior to the inpatient admission through the Day 7 (Cohorts 1 and 3) or Day 17 (Cohort 2) follow-up visit.
Who cannot join
- 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.
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- 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.
- Subjects who have donated or lost more than 500 mL 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital - Medicine - Infectious Diseases
Baltimore, Maryland, 21287-0005
About this study
Official title: A Phase I C Clinical Study With Influenza Antiviral DAS181-F03: Double-Blind, Randomized, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study in Healthy Adults
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.
Read the detailed description
Influenza is typically caused by infection of two types of viruses, influenza virus A and influenza virus B. The host cell receptors for influenza A and B viruses are cell surface sialic acids (SA). The Actinomyces viscosus sialidase Catalytic Domain (AvCD) sialidase domain in DAS181 selectively cleaves sialic acids from the host cells, thereby rendering them inaccessible to the influenza viral particles that require sialic acids as receptors. By binding to the negatively charged glycosaminoglycans on the surface of airway epithelial cells, the cationic C-terminal Amphiregulin (AR) tag anchors DAS181 on the respiratory epithelium, thereby improving treatment potency and retention of the investigational drug on the airway surface. DAS181 is the first candidate in a new class of influenza therapeutics, viral receptor inactivator. The primary objective is to determine the safety and tolerability of DAS181 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler (DPI) in healthy adults. The secondary objective of this study is to investigate the pharmacokinetic and immunologic profile of DAS181 encapsulated dry powder dose to dose and compared to placebo when administered by oral inhalation using a DPI in healthy adults. A total of 27 normal healthy male and female subjects (9 per cohort) 18 to 45 years of age at the time of screening will be included in this study. This study will be a double-blind, randomized, placebo-controlled study of a three cohorts. 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.) The study will proceed to the next stage of multiple daily doses based on meeting study defined criteria. Within each dose cohort of nine, subjects will be randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the inpatient clinic on the day prior to first dose (Day -1). The subjects in single dose cohorts (Cohort 1 and 3) will stay in the inpatient unit for dosing (Day 0) and one day after dosing (Day 1). Subjects in Cohort 1 will come back for follow-up visits on Study Days 2, 3, 7, 14, and 30 . Subjects in Cohort 3 will return on Days 2, 3, 4, 5, 8. 10, 16, and 30. The subjects in the 10-day, multiple-dose cohort (Cohort 2) will stay in the inpatient clinic from Day -1 to 1 and will be required to come back for follow-up visits on Days 2 - 7. They will be seen (and optionally readmitted) Days 8 - 10 and will be seen as outpatients Days 11, 13, 15, 17, 20, 22, 24, and 27. All subjects will be asked to return for an additional blood draw to conduct an immunogenicity test at 90 days post final dosing. Subjects will be trained in proper inhalation techniques prior to dosing using a low range inspiratory flow measurement device.
- Conditions
- Influenza
- Being tested
- Placebo, DAS181
- Keywords
- influenza, DAS181, antiviral
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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).
DAS181Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2: 20 mg 10 days | Experimental | Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg). Receives: Drug: Placebo; Drug: DAS181 |
| Cohort 3: 30 mg 1 day | Experimental | Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg). Receives: Drug: Placebo; Drug: DAS181 |
| Cohort 1: 20 mg, 1 day | Experimental | Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg). Receives: Drug: Placebo; Drug: DAS181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 90
Secondary outcomes (2)
Blood samples to determine the pharmacokinetic profile of DAS 181.
Measured: Day 0 through Day 30.
Blood samples to determine the immunogenic profile of DAS 181.
Measured: Day 0 through Day 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173224
- Sponsor's protocol ID
- 09-0104
- Other IDs
- N01AI80026C
- Status last verified
- Nov 2012
- First submitted
- 29 Jul 2010
- Last updated
- 19 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I C Clinical Study With Influenza Antiviral DAS181-F03: Double-Blind, Randomized, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study in Healthy Adults
- ClinicalTrials.gov ID
- NCT01173224
- Acronym / sponsor ID
- 09-0104
- Conditions
- Influenza
- Keywords
- influenza, DAS181, antiviral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Influenza is typically caused by infection of two types of viruses, influenza virus A and influenza virus B. The host cell receptors for influenza A and B viruses are cell surface sialic acids (SA). The Actinomyces viscosus sialidase Catalytic Domain (AvCD) sialidase domain in DAS181 selectively cleaves sialic acids from the host cells, thereby rendering them inaccessible to the influenza viral particles that require sialic acids as receptors. By binding to the negatively charged glycosaminoglycans on the surface of airway epithelial cells, the cationic C-terminal Amphiregulin (AR) tag anchors DAS181 on the respiratory epithelium, thereby improving treatment potency and retention of the investigational drug on the airway surface. DAS181 is the first candidate in a new class of influenza therapeutics, viral receptor inactivator. The primary objective is to determine the safety and tolerability of DAS181 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler (DPI) in healthy adults. The secondary objective of this study is to investigate the pharmacokinetic and immunologic profile of DAS181 encapsulated dry powder dose to dose and compared to placebo when administered by oral inhalation using a DPI in healthy adults. A total of 27 normal healthy male and female subjects (9 per cohort) 18 to 45 years of age at the time of screening will be included in this study. This study will be a double-blind, randomized, placebo-controlled study of a three cohorts. 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.) The study will proceed to the next stage of multiple daily doses based on meeting study defined criteria. Within each dose cohort of nine, subjects will be randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the inpatient clinic on the day prior to first dose (Day -1). The subjects in single dose cohorts (Cohort 1 and 3) will stay in the inpatient unit for dosing (Day 0) and one day after dosing (Day 1). Subjects in Cohort 1 will come back for follow-up visits on Study Days 2, 3, 7, 14, and 30 . Subjects in Cohort 3 will return on Days 2, 3, 4, 5, 8. 10, 16, and 30. The subjects in the 10-day, multiple-dose cohort (Cohort 2) will stay in the inpatient clinic from Day -1 to 1 and will be required to come back for follow-up visits on Days 2 - 7. They will be seen (and optionally readmitted) Days 8 - 10 and will be seen as outpatients Days 11, 13, 15, 17, 20, 22, 24, and 27. All subjects will be asked to return for an additional blood draw to conduct an immunogenicity test at 90 days post final dosing. Subjects will be trained in proper inhalation techniques prior to dosing using a low range inspiratory flow measurement device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 2: 20 mg 10 days | Experimental | Drug: Placebo, Drug: DAS181Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg). |
| Cohort 3: 30 mg 1 day | Experimental | Drug: Placebo, Drug: DAS181Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg). |
| Cohort 1: 20 mg, 1 day | Experimental | Drug: Placebo, Drug: DAS181Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo: 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). | Drug | Cohort 1: 20 mg, 1 day, Cohort 2: 20 mg 10 days, Cohort 3: 30 mg 1 day |
| DAS181DAS181 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). | Drug | Cohort 1: 20 mg, 1 day, Cohort 2: 20 mg 10 days, Cohort 3: 30 mg 1 day |
Primary outcome
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.
Time frame: Up to Day 90
2 secondary outcomes
Blood samples to determine the pharmacokinetic profile of DAS 181.
Time frame: Day 0 through Day 30.
Blood samples to determine the immunogenic profile of DAS 181.
Time frame: Day 0 through Day 90.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DAS181 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.