InfluenzaPhase 1NCT00527865
Single Dose Escalating Study of DAS181 in Adults
A Phase 1 study testing DAS181 in people with Influenza, run by Ansun Biopharma, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability, and systemic exposure of an experimental influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is administered via oral inhalation using a special device. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Healthy, non-smoking adult male and female volunteers between the ages of 18 and 65(inclusive)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study 181-1-06-01 - Phase 1A Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalating Study in Healthy Adults
This study will evaluate the safety, tolerability, and systemic exposure of an experimental influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is administered via oral inhalation using a special device. Study participants will include up to 60 healthy, non-smoking males and females, ages 18-65. They will be given either DAS181 or placebo. Participants will remain in the clinic overnight to be watched for health changes for 24 hours after receiving the medication. Study procedures include: physical exams, chest x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs. Follow-up visits will occur on study days 2, 7, 14 +/- 1 day, and 30 +/- 2 days. Participants will be involved in the study for up to 61 days, which includes the screening period.
Read the detailed description
The objective of this study is to investigate the safety, tolerability and pharmacokinetics of a single dose of DAS181 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler in healthy adults. Primary study outcome measures are the safety and tolerability of single-dose DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg, as measured in the following parameters: adverse events, physical exam, vital signs, hematology, clinical chemistry, blood coagulation, complement activation, haptoglobin and immunogenicity, urinalysis, throat swab for bacterial culture, ECG, chest X-ray, and spirometric lung function. Secondary outcome measures are the systemic exposure and pharmacokinetic parameters of DAS181. This phase 1 study will be a double-blind, randomized, placebo-controlled, single-dose escalation study conducted at Comprehensive Phase One Miramar campus. Thirty-six to 60 healthy male and female volunteers, 18-65 years (inclusive), will be enrolled in 4 separate steps. Each enrollment will recruit 9 subjects for one of the 4 dose groups. Within each dose group, the participants will be randomly assigned to placebo or DAS181, at 1:2 ratios. The subjects will receive a single-dose treatment by placebo (10.5 mg lactose), or by DAS181 at one of 4 doses: 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg. The subjects will be screened and enrolled within 28 days prior to dosing of the study drug. The study will be initiated with 0.5 mg dose. Escalation to the next dose will be contingent upon meeting the dose escalation criteria after the study day 7 post dosing follow-up visit (Visit 4). The day of dosing is always defined as Day 0 (or study day 0), regardless of the step or cohort. All future visits and time periods are referenced to the day of dosing. Administration of DAS181 or placebo will be given under the supervision of the study staff. Subjects will enter the inpatient clinic on day -1, the evening prior to dosing. Subjects will remain in the inpatient clinic for 24 hours post exposure to be observed for signs of adverse events (AEs). After the 24-hour inpatient observation period, participants will be discharged if they are deemed healthy at that point. All subjects must come back for follow-up visits on the following study days: 2, 7, 14 (±1 day), and 30 (±2 days).
- Conditions
- Influenza
- Being tested
- DAS181, Placebo
- Keywords
- Influenza, Flu, DAS181, Fludase
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181Drug
DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
PlaceboDrug
Capsules containing 10.5 mg of lactose will be supplied as placebo.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6 subjects DAS181 dosage 0.5 mg; 3 subjects placebo Receives: Drug: DAS181; Drug: Placebo |
| 2 | Experimental | 6 subjects DAS181 dosage 1.0 mg; 3 subjects placebo Receives: Drug: DAS181; Drug: Placebo |
| 3 | Experimental | 6 subjects DAS181 dosage 2.25 mg; 3 subjects placebo Receives: Drug: DAS181; Drug: Placebo |
| 4 | Experimental | 6 subjects DAS181 dosage 4.5 mg; 3 subjects placebo Receives: Drug: DAS181; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single-dose of DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
Measured: Duration of study
Secondary outcomes (1)
The pharmacokinetic parameters of DAS181.
Measured: Pre-dosing, 1, 2, 4, 6, 8, 12 and 24 hours post dosing, Day 2, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionJan 2009
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.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ansun Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527865
- Sponsor's protocol ID
- 06-0082
- Other IDs
- 181-1-06-01
- Status last verified
- Jan 2009
- First submitted
- 10 Sep 2007
- Last updated
- 8 Jan 2009
- Results posted
- 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 8 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 181-1-06-01 - Phase 1A Clinical Study With DAS181: Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalating Study in Healthy Adults
- ClinicalTrials.gov ID
- NCT00527865
- Acronym / sponsor ID
- 06-0082
- Conditions
- Influenza
- Keywords
- Influenza, Flu, DAS181, Fludase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ansun Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Sep 2007 (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 evaluate the safety, tolerability, and systemic exposure of an experimental influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is administered via oral inhalation using a special device. Study participants will include up to 60 healthy, non-smoking males and females, ages 18-65. They will be given either DAS181 or placebo. Participants will remain in the clinic overnight to be watched for health changes for 24 hours after receiving the medication. Study procedures include: physical exams, chest x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs. Follow-up visits will occur on study days 2, 7, 14 +/- 1 day, and 30 +/- 2 days. Participants will be involved in the study for up to 61 days, which includes the screening period.
Detailed description
The objective of this study is to investigate the safety, tolerability and pharmacokinetics of a single dose of DAS181 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler in healthy adults. Primary study outcome measures are the safety and tolerability of single-dose DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg, as measured in the following parameters: adverse events, physical exam, vital signs, hematology, clinical chemistry, blood coagulation, complement activation, haptoglobin and immunogenicity, urinalysis, throat swab for bacterial culture, ECG, chest X-ray, and spirometric lung function. Secondary outcome measures are the systemic exposure and pharmacokinetic parameters of DAS181. This phase 1 study will be a double-blind, randomized, placebo-controlled, single-dose escalation study conducted at Comprehensive Phase One Miramar campus. Thirty-six to 60 healthy male and female volunteers, 18-65 years (inclusive), will be enrolled in 4 separate steps. Each enrollment will recruit 9 subjects for one of the 4 dose groups. Within each dose group, the participants will be randomly assigned to placebo or DAS181, at 1:2 ratios. The subjects will receive a single-dose treatment by placebo (10.5 mg lactose), or by DAS181 at one of 4 doses: 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg. The subjects will be screened and enrolled within 28 days prior to dosing of the study drug. The study will be initiated with 0.5 mg dose. Escalation to the next dose will be contingent upon meeting the dose escalation criteria after the study day 7 post dosing follow-up visit (Visit 4). The day of dosing is always defined as Day 0 (or study day 0), regardless of the step or cohort. All future visits and time periods are referenced to the day of dosing. Administration of DAS181 or placebo will be given under the supervision of the study staff. Subjects will enter the inpatient clinic on day -1, the evening prior to dosing. Subjects will remain in the inpatient clinic for 24 hours post exposure to be observed for signs of adverse events (AEs). After the 24-hour inpatient observation period, participants will be discharged if they are deemed healthy at that point. All subjects must come back for follow-up visits on the following study days: 2, 7, 14 (±1 day), and 30 (±2 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DAS181, Drug: Placebo6 subjects DAS181 dosage 0.5 mg; 3 subjects placebo |
| 2 | Experimental | Drug: DAS181, Drug: Placebo6 subjects DAS181 dosage 1.0 mg; 3 subjects placebo |
| 3 | Experimental | Drug: DAS181, Drug: Placebo6 subjects DAS181 dosage 2.25 mg; 3 subjects placebo |
| 4 | Experimental | Drug: DAS181, Drug: Placebo6 subjects DAS181 dosage 4.5 mg; 3 subjects placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg. | Drug | 1, 2, 3, 4 |
| PlaceboCapsules containing 10.5 mg of lactose will be supplied as placebo. | Drug | 1, 2, 3, 4 |
Primary outcome
Safety and tolerability of a single-dose of DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.
Time frame: Duration of study
1 secondary outcome
The pharmacokinetic parameters of DAS181.
Time frame: Pre-dosing, 1, 2, 4, 6, 8, 12 and 24 hours post dosing, Day 2, and Day 7
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 8 Jan 2009.
- 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.
- NexBio, IncLink provided by the sponsor.
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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 Ansun Biopharma, Inc. 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?
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 8 Jan 2009. 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 a single-dose of DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg. (time frame: Duration of study). 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 NCT00527865, 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 8 Jan 2009.