Influenza APhase 2NCT02071914
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
A Phase 2 study testing CT-P27 in people with Influenza A, run by Celltrion at 1 site in United Kingdom.
Trial summary
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A
- What is being tested?
- CT-P27
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2014to 19 Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy Male \& Female volunteers
Who cannot join
- Current clinically significant disease
- Pregnant or nursing mother
- Abnormal pulmonary function, nose or nasopharynx
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.
Read the detailed description
This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.
- Conditions
- Influenza A
- Being tested
- CT-P27, Placebo
- Keywords
- efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P27Drug
Influenza A treatment drug.
PlaceboDrug
Placebo.
| Study group | Role | What they receive |
|---|---|---|
| CT-P27 10mg/kg | Experimental | CT-P27 will be administrated once in IV infusion. Receives: Drug: CT-P27 |
| CT-P27 20mg/kg | Experimental | CT-P27 will be administrated once in IV infusion. Receives: Drug: CT-P27 |
| Placebo | Placebo comparator | Placebo will be administrated once in IV infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
Measured: Three times a day from Day 1(the day after virus inoculation) to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start15 Feb 2014
- Primary completion19 May 2014
- Study completion19 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza AStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SuEun Song, Study director, Celltrion Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071914
- Sponsor's protocol ID
- CT-P27 2.1
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2014
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
- ClinicalTrials.gov ID
- NCT02071914
- Acronym / sponsor ID
- CT-P27 2.1
- Conditions
- Influenza A
- Keywords
- efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2014 (actual)
- Primary completion
- 19 May 2014 (actual)
- Study completion
- 19 Jun 2014 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.
Detailed description
This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT-P27 10mg/kg | Experimental | Drug: CT-P27CT-P27 will be administrated once in IV infusion. |
| CT-P27 20mg/kg | Experimental | Drug: CT-P27CT-P27 will be administrated once in IV infusion. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administrated once in IV infusion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Male \& Female volunteers
Key exclusion criteria (3 listed)
- Current clinically significant disease
- Pregnant or nursing mother
- Abnormal pulmonary function, nose or nasopharynx
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 |
|---|---|---|
| CT-P27Influenza A treatment drug. | Drug | CT-P27 10mg/kg, CT-P27 20mg/kg |
| PlaceboPlacebo. | Drug | Placebo |
Primary outcome
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
Time frame: Three times a day from Day 1(the day after virus inoculation) to Day 9
AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Healthy Participants
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.
SuEun Song study director
Celltrion Inc.
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 CT-P27 in people with Influenza A, run by Celltrion at 1 site in United Kingdom.
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 3 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 Apr 2020. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR (time frame: Three times a day from Day 1(the day after virus inoculation) to Day 9). 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 Apr 2020.