InfluenzaPhase 1NCT02045472
A Study of VIS410 to Assess Safety and Pharmacokinetics
A Phase 1 study testing VIS410 in people with Influenza, run by Visterra, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VIS410
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Body mass index between 18 and 33 kg/m2, inclusive
- Normal labs
- Volunteers agree to use acceptable contraceptive measures
Who cannot join
- Prior receipt of antibody or biologic therapy
- History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias
- Any chronic condition requiring daily prescription or over the counter medication
- History of a previous severe allergic reaction
- Drug or alcohol abuse within previous 12 months
- Positive serology for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
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- Positive pregnancy test
- Breast feeding
- Positive drug or alcohol test at screening or check-in
- Receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VIS410) to Influenza Type A Hemagglutinin
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.
- Conditions
- Influenza
- Being tested
- VIS410, Placebo
- Keywords
- Influenza, Monoclonal antibody
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIS410Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| VIS410 | Experimental | VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg Receives: Drug: VIS410 |
| Placebo | Placebo comparator | Placebo administered as a single infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
Incidence of adverse events
Measured: 120 days post-infusion
Secondary outcomes (2)
Pharmacokinetic analysis
Serum concentration-time profile
Measured: 56 days post-infusion
Immunogenicity
Detect and measure anti-drug antibodies to VIS410
Measured: 120 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visterra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J K Berg, MD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045472
- Sponsor's protocol ID
- VIS-C001
- Status last verified
- May 2015
- First submitted
- 21 Jan 2014
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wollacott AM, Boni MF, Szretter KJ, Sloan SE, Yousofshahi M, Viswanathan K, Bedard S, Hay CA, Smith PF, Shriver Z, Trevejo JM. Safety and Upper Respiratory Pharmacokinetics of the Hemagglutinin Stalk-Binding Antibody VIS410 Support Treatment and Prophylaxis Based on Population Modeling of Seasonal Influenza A Outbreaks. EBioMedicine. 2016 Feb 26;5:147-55. doi: 10.1016/j.ebiom.2016.02.021. eCollection 2016 Mar.
PubMed 27077121
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VIS410) to Influenza Type A Hemagglutinin
- ClinicalTrials.gov ID
- NCT02045472
- Acronym / sponsor ID
- VIS-C001
- Conditions
- Influenza
- Keywords
- Influenza, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Visterra, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jan 2014 (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.
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIS410 | Experimental | Drug: VIS410VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered as a single infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Body mass index between 18 and 33 kg/m2, inclusive
- Normal labs
- Volunteers agree to use acceptable contraceptive measures
Key exclusion criteria (10 listed)
- Prior receipt of antibody or biologic therapy
- History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias
- Any chronic condition requiring daily prescription or over the counter medication
- History of a previous severe allergic reaction
- Drug or alcohol abuse within previous 12 months
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 |
|---|---|---|
| VIS410 | Drug | VIS410 |
| Placebo | Drug | Placebo |
Primary outcome
Safety assessment
Time frame: 120 days post-infusion
Incidence of adverse events
2 secondary outcomes
Pharmacokinetic analysis
Time frame: 56 days post-infusion
Immunogenicity
Time frame: 120 days post-infusion
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 14 May 2015.
- Derived from this study: PubMed 27077121Wollacott AM, Boni MF, Szretter KJ, Sloan SE, Yousofshahi M, Viswanathan K, Bedard S, Hay CA, Smith PF, Shriver Z, Trevejo JM. Safety and Upper Respiratory Pharmacokinetics of the Hemagglutinin Stalk-Binding Antibody VIS410 Support Treatment and Prophylaxis Based on Population Modeling of Seasonal Influenza A Outbreaks. EBioMedicine. 2016 Feb 26;5:147-55. doi: 10.1016/j.ebiom.2016.02.021. eCollection 2016 Mar.
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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.
J K Berg, MD principal investigator
Davita Clinical Research
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 VIS410 in people with Influenza, run by Visterra, 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 4 inclusion and 10 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 14 May 2015. 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?
Safety assessment (time frame: 120 days post-infusion). 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 NCT02045472, 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 14 May 2015.