InfluenzaPhase 2NCT01740063
Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza
A Phase 2 study testing DAS181-F02 formulation and DAS181-F04 formulation in people with Influenza, run by Ansun Biopharma, Inc. at 1 site in United States.
Trial summary
This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza virus (IFV). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Influenza
- What is being tested?
- DAS181-F02 formulation and DAS181-F04 formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 423 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2014
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a physical exam based on medical history.
- 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 70 years of age (inclusive).
- Subjects must weigh at least 50 kg and must have a Body Mass Index (BMI) of no greater than 40.00.
- Febrile, oral temperature ≥100.4°F (≥38.0°C) in combination with symptoms
- At least one respiratory symptom:
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- Cough
- Sore throat
- Wheezing
- Sneezing
- Shortness of breath
- Nasal congestion
- Earache
- Pleuritic chest pain
- At least one constitutional symptom:
- Headache
- Myalgia (body aches and pains)
- Fever or feverish (sweat/chills)
- Prostration (fatigue, tired, lacking energy)
- Positive rapid antigen test (RAT) for influenza performed using FDA-cleared and CLIA-waived commercially available rapid antigen test supplied by the sponsor.
- Blood pressure within normal limits (systolic 90-150 mmHg; diastolic 50-95 mmHg) and heart rate between 45 and 140 beats per minute.
- Onset of symptoms no more than 48 hours prior to diagnosis.
- Note: Time of onset of illness is defined as either:
- the time when the temperature was first measured as elevated (38 C) OR
- the time when the subject experienced the presence of at least one symptom, whichever occurs first 11. Female subjects must be post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods may include intrauterine device, spermicide, barrier and hormonal contraception. A female subject must agree to practice an acceptable method of birth control during the study period. All female subjects regardless of menopausal status or surgical history must have had a negative urine pregnancy test during the screening visit and prior to dosing.
- 12. Male subjects must agree to use medically accepted form of contraception during the study period.
Who cannot join
- Have received any investigational drug or investigational vaccine within 8 weeks prior to study drug dosing.
- Have had a serious adverse reaction or previous episode of anaphylaxis related to any drug.
- Have received blood products within 6 months of study enrollment.
- Have concurrent cystic fibrosis or emphysema.
- Have sickle cell disease.
- Known IGE mediated allergic response to lactose (not lactose intolerance).
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- Any history of congenital or acquired bleeding abnormalities.
- Existence of any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.
- Use of antiviral influenza medications within 10 days prior to screening (Subjects will be prohibited from taking antiviral influenza medications during the course of the trial).
- Current clinical evidence of a recognized or suspected uncontrolled non-influenza infectious illness with onset prior to screening.
- Known hypersensitivity to DAS181.
- Women who are pregnant (urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding.
- Uncontrolled seizure disorder or history of seizure activity within 12 months prior to study participation.
- Any significant findings in the subject's medical history or physical examination that, in the opinion of the investigator, would affect subject safety or compliance with the dosing schedule.
- Subjects with history of asthma or chronic obstructive pulmonary disease (COPD) requiring the use of acute or chronic medication in the past 3 years.
- Subjects with acute diagnosis of a chronic medical condition within the last 3 months.
- Subjects with a chronic medical condition that have initiated or changed dosing or regimen of prescription medications to treat the chronic medical condition within the last 3 months. (Any changes in chronic medications during the 28 day enrollment period will be captured in the source documentation under concomitant medications).
- Subjects with current or previous history of the following: systemic disorders, immunological disorders, hepatitis B virus (HBV), hepatitis C virus (HCV) or cirrhosis, transplant recipients, or other immunosuppressive illness.
- Subjects with cancer or history of hematologic malignancy. Cancer is defined as any active neoplastic diseases excluding noninvasive basal cell carcinoma.
- Subjects who have had or are scheduled to have surgery within 30 days of initiation of the study.
- Subjects who have donated or lost more than 500 mL of blood in the two months prior to screening.
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance.
- Family members of site staff directly involved in study conduct are excluded from study participation.
- Subjects with an oxygen saturation (Sa02) level of <92% as measured by pulse oximeter.
- Subjects with a modified CURB-65 score of 2 or higher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza.
This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza virus (IFV).
Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a placebo group.
Read more
The modified intent to treat (mITT) analysis set will include subjects with confirmed influenza as documented by qPCR or TCID50. The full analysis set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Per protocol, the safety analysis sets are described below in statistical methods.
A subpopulation of 60 participants will also have additional PK and Immunogenicity blood samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all study visits.
- Conditions
- Influenza
- Being tested
- DAS181-F02 formulation, DAS181-F04 formulation, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181-F02 formulationDrug
DAS181-F04 formulationDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DAS181-F02 formulation | Experimental | DAS181 10 mg dose for three days of the F02 formulation Receives: Drug: DAS181-F02 formulation |
| DAS181-F04 formulation | Experimental | DAS181 20 mg dose group for three days of the F04 formulation, Receives: Drug: DAS181-F04 formulation |
| Placebo | Placebo comparator | placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Unacceptable Serious Adverse Events due to safety and toxicity Safety and toxicity profile: Unacceptable Serious Adverse Events Safety and toxicity profile: Unacceptable Serious Adverse Events
Because of the possibility of unacceptable or excessive defined serious adverse events during the treatment period or the study enrollment period, a stopping rule for safety/tolerability has been introduced in the design.
The following two stopping rule criteria will initiate an ad hoc DSMB data evaluation.
- 5% with a related SAE post-dose Day 1 through Day 28 , or
- 15% with related DAIDS toxicity Grade 3 and 4 laboratory abnormalities post-dose Day 1 through Day 28
- Grade 3 laboratory abnormalities in hematology or serum chemistry, excluding absolute neutrophils and absolute lymphocytes.
- Grade 4 laboratory abnormalities in hematology or serum chemistry including absolute neutrophils and absolute lymphocytes
Changes (absolute and percent) from baseline in influenza viral load from Day 1 to Day 2 as measured by quantitative polymerase chain reaction (qPCR) from pharyngeal wash and nasal wash samples.
Measured: Participants will be followed (up to one year) for the duration of the study and outcome measure will be reviewed at the end of study. The expected end of study is Sept. 2013.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2014
- Study completionJan 2014
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ansun Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740063
- Sponsor's protocol ID
- DAS181-2-04
- Status last verified
- Jul 2019
- First submitted
- 28 Nov 2012
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza.
- ClinicalTrials.gov ID
- NCT01740063
- Acronym / sponsor ID
- DAS181-2-04
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Ansun Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Dec 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 protocol will seek to enroll 372 adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza virus (IFV).
Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a placebo group.
The modified intent to treat (mITT) analysis set will include subjects with confirmed influenza as documented by qPCR or TCID50. The full analysis set will be used for activity analysis and will include all randomized subjects with baseline and treatment data. Per protocol, the safety analysis sets are described below in statistical methods.
A subpopulation of 60 participants will also have additional PK and Immunogenicity blood samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DAS181-F02 formulation | Experimental | Drug: DAS181-F02 formulationDAS181 10 mg dose for three days of the F02 formulation |
| DAS181-F04 formulation | Experimental | Drug: DAS181-F04 formulationDAS181 20 mg dose group for three days of the F04 formulation, |
| Placebo | Placebo comparator | Drug: Placeboplacebo group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male and female subjects in generally good health in the opinion of the investigator as determined by vital signs, medical history, and a physical exam based on medical history.
- 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 70 years of age (inclusive).
- Subjects must weigh at least 50 kg and must have a Body Mass Index (BMI) of no greater than 40.00.
- Febrile, oral temperature ≥100.4°F (≥38.0°C) in combination with symptoms
Key exclusion criteria (25 listed)
- Have received any investigational drug or investigational vaccine within 8 weeks prior to study drug dosing.
- Have had a serious adverse reaction or previous episode of anaphylaxis related to any drug.
- Have received blood products within 6 months of study enrollment.
- Have concurrent cystic fibrosis or emphysema.
- Have sickle cell disease.
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 |
|---|---|---|
| DAS181-F02 formulation | Drug | DAS181-F02 formulation |
| DAS181-F04 formulation | Drug | DAS181-F04 formulation |
| Placebo | Drug | Placebo |
Primary outcome
Number of participants with Unacceptable Serious Adverse Events due to safety and toxicity Safety and toxicity profile: Unacceptable Serious Adverse Events Safety and toxicity profile: Unacceptable Serious Adverse Events
Time frame: Participants will be followed (up to one year) for the duration of the study and outcome measure will be reviewed at the end of study. The expected end of study is Sept. 2013.
Because of the possibility of unacceptable or excessive defined serious adverse events during the treatment period or the study enrollment period, a stopping rule for safety/tolerability has been introduced in the design. The following two stopping rule criteria will initiate an ad hoc DSMB data evaluation. * 5% with a related SAE post-dose Day 1 through Day 28 , or * 15% with related DAIDS toxicity Grade 3 and 4 laboratory abnormalities post-dose Day 1 through Day 28 * Grade 3 laboratory abnormalities in hematology or serum chemistry, excluding absolute neutrophils and absolute lymphocytes. * Grade 4 laboratory abnormalities in hematology or serum chemistry including absolute neutrophils and absolute lymphocytes Changes (absolute and percent) from baseline in influenza viral load from Day 1 to Day 2 as measured by quantitative polymerase chain reaction (qPCR) from pharyngeal wash and nasal wash samples.
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 Jul 2019.
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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 2 study testing DAS181-F02 formulation and DAS181-F04 formulation 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?
The sponsor lists 26 inclusion and 25 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 8 Jul 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of participants with Unacceptable Serious Adverse Events due to safety and toxicity Safety and toxicity profile: Unacceptable Serious Adverse Events Safety and toxicity profile: Unacceptable Serious Adverse Events (time frame: Participants will be followed (up to one year) for the duration of the study and outcome measure will be reviewed at the end of study. The expected end of study is Sept. 2013.). 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 8 Jul 2019.