InfluenzaPhase 1NCT01651494
Influenza Antiviral DAS-181-F04 in Healthy Adults
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
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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2011to 18 Sep 2012
- 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 sub-investigator 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 17.5-35. Actual lower weight limit may be 50 kg, if BMI is in the range indicated. -No 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 200ms, QRS interval < 120ms, and confirmed QTc interval </= 440ms. -Blood pressure within normal limits (systolic 86 - 140mmHg; diastolic 50 - 90 mmHg) and heart rate between 45 and 100 beats per minute. -Chest X-ray shows no clinically significant abnormalities. -Forced expiratory volume in 1 second (FEV1) will be greater than 80% predicted; note: only one baseline value for FEV1 can be used to support inclusion criterion. -Negative Human Immunodeficiency Virus (HIV), HBSAg, and Hepatitis C Virus (HCV) antibody screening tests. -Negative screening tests for: marijuana, cocaine metabolite, amphetamines, opiates, PCP, barbiturates, benzodiazepines, and ethanol. -Subjects with the following laboratory criteria within provided range (see Appendix B): --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 obtained 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 utilizing 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 alcohol or participate in strenuous physical activity or exercise from 24 hours prior to Day -1 through the Day 6 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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center - Infectious Diseases
Baltimore, Maryland, 21224-2735
About this study
Official title: A Phase 1 Clinical Study With Influenza Antiviral DAS181-F04: Double-Blind, Randomized, Placebo-Controlled, Multi Dose Study in Healthy Adults
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.
Read the detailed description
This study will be a double-blind, randomized, placebo-controlled study. The subjects will receive a single-dose treatment of DAS181-F04 or placebo at a targeted delivered dose of 20mg each day for three days. The subjects will be evaluated on the day before the initial dose (Day -1) and randomly assigned to DAS181-F04 or placebo in a 2:1 ratio. Subjects will be evaluated prior to dosing on Days 0, 1 and 2. Additional follow-up evaluations will occur one day after completion of dosing (Day 3) and on Days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days) and 90 (+/-10 days). The primary objective is to determine the safety and tolerability of DAS181-F04 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler (DPI) in healthy adults. The secondary objective 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 9 subjects, healthy male and female subjects, ages 18 to 45 years will be enrolled. Subjects will be randomized 2:1 ratio, wherein 6 subjects will receive the active drug and 3 subjects will receive placebo. Subjects may be replaced if a subject withdraws within 7 days (Day 9) after receipt of the final study drug dose.
- Conditions
- Influenza
- Being tested
- DAS181, Placebo
- Keywords
- DAS181, Influenza, inhalation, inpatient clinic, Multi-Dose, recombinant neuraminidase
- Medical subject headings
- Influenza, Human, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181Drug
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| DAS181-F04 | Active comparator | DAS181-F04: 20 mg single-dose each day via inhalation for 3 days; 6 subjects Receives: Drug: DAS181 |
| Placebo | Placebo comparator | Placebo: 20 mg single-dose each day via inhalation for 3 days; 3 subjects Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to day 90
Secondary outcomes (2)
Immunogenicity responses: Blood samples for the immunogenetic profile of DAS181- F04 will be collected
Measured: 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)
Measured: Day 0-4, 6, 9, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study start12 Aug 2011
- Primary completion18 Sep 2012
- Study completion18 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651494
- Sponsor's protocol ID
- 12-0009
- Other IDs
- HHSN272201500007I
- Status last verified
- 5 Apr 2017
- First submitted
- 12 Jul 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 26391974
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study With Influenza Antiviral DAS181-F04: Double-Blind, Randomized, Placebo-Controlled, Multi Dose Study in Healthy Adults
- ClinicalTrials.gov ID
- NCT01651494
- Acronym / sponsor ID
- 12-0009
- Conditions
- Influenza
- Keywords
- DAS181, Influenza, inhalation, inpatient clinic, Multi-Dose, recombinant neuraminidase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 12 Aug 2011 (actual)
- Primary completion
- 18 Sep 2012 (actual)
- Study completion
- 18 Sep 2012 (actual)
- First posted
- 27 Jul 2012 (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.
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.
Detailed description
This study will be a double-blind, randomized, placebo-controlled study. The subjects will receive a single-dose treatment of DAS181-F04 or placebo at a targeted delivered dose of 20mg each day for three days. The subjects will be evaluated on the day before the initial dose (Day -1) and randomly assigned to DAS181-F04 or placebo in a 2:1 ratio. Subjects will be evaluated prior to dosing on Days 0, 1 and 2. Additional follow-up evaluations will occur one day after completion of dosing (Day 3) and on Days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days) and 90 (+/-10 days). The primary objective is to determine the safety and tolerability of DAS181-F04 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler (DPI) in healthy adults. The secondary objective 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 9 subjects, healthy male and female subjects, ages 18 to 45 years will be enrolled. Subjects will be randomized 2:1 ratio, wherein 6 subjects will receive the active drug and 3 subjects will receive placebo. Subjects may be replaced if a subject withdraws within 7 days (Day 9) after receipt of the final study drug dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAS181-F04 | Active comparator | Drug: DAS181DAS181-F04: 20 mg single-dose each day via inhalation for 3 days; 6 subjects |
| Placebo | Placebo comparator | Other: PlaceboPlacebo: 20 mg single-dose each day via inhalation for 3 days; 3 subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Male and female subjects in good health in the opinion of the site Principal Investigator (PI) or sub-investigator 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 17.5-35. Actual lower weight limit may be 50 kg, if BMI is in the range indicated. -No 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 200ms, QRS interval < 120ms, and confirmed QTc interval </= 440ms. -Blood pressure within normal limits (systolic 86 - 140mmHg; diastolic 50 - 90 mmHg) and heart rate between 45 and 100 beats per minute. -Chest X-ray shows no clinically significant abnormalities. -Forced expiratory volume in 1 second (FEV1) will be greater than 80% predicted; note: only one baseline value for FEV1 can be used to support inclusion criterion. -Negative Human Immunodeficiency Virus (HIV), HBSAg, and Hepatitis C Virus (HCV) antibody screening tests. -Negative screening tests for: marijuana, cocaine metabolite, amphetamines, opiates, PCP, barbiturates, benzodiazepines, and ethanol. -Subjects with the following laboratory criteria within provided range (see Appendix B): --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 obtained 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 utilizing 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 alcohol or participate in strenuous physical activity or exercise from 24 hours prior to Day -1 through the Day 6 follow-up visit.
Key exclusion criteria (1 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 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.
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 |
|---|---|---|
| DAS181DAS181-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 | Drug | DAS181-F04 |
| PlaceboPlacebo: 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 | Other | Placebo |
Primary outcome
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)
Time frame: up to day 90
2 secondary outcomes
Immunogenicity responses: Blood samples for the immunogenetic profile of DAS181- F04 will be collected
Time frame: 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)
Time frame: Day 0-4, 6, 9, and 16
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 7 Apr 2017.
- Derived from this study: PubMed 26391974Zenilman 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.
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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 1 inclusion and 1 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 7 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
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) (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?
On the ClinicalTrials.gov record for NCT01651494, which also lists 1 linked publication.
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 7 Apr 2017.