InfluenzaPhase 2NCT03903718
Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza
A Phase 2 study testing Oseltamivir and MEDI8852 in people with Influenza, run by MedImmune LLC.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of MEDI8852 for the treatment of influenza caused by a wild type A/H1N1 challenge strain in healthy, influenza serosusceptible adults. 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?
- Oseltamivir and MEDI8852
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2020to 9 Oct 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 through 65 years at the time of screening.
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA, European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- For subjects enrolled in Part 1 and Part 2 of the study, agree to remain restricted to an inpatient unit until released (anticipated to be 3 days and 2 nights for Part 1 and 9 days and 8 nights for Part 2).
- Able to complete the follow-up period through Day 60 as required by the protocol.
- Female subjects of childbearing potential must also have a negative urine or blood pregnancy test at screening, on Day -1 and on and Day 1 prior to randomization
- Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception for at least 2 days prior to the first dose of study drug and must agree to continue using such precautions through Day 60 of the study; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
Who cannot join
- History of allergic disease or reactions likely to be exacerbated by any component of the study drug, MEDI8852.
- For subjects enrolled in Part 2 of the study, history of allergic disease or reactions likely to be exacerbated by any component of OS.
- History of allergic disease or reactions to eggs or egg proteins
- Any fever ≥ 100.4°F (≥ 38.0°C) regardless of route of measurement and/or respiratory illness (eg, cough or sore throat) within 7 days prior to randomization.
- Renal impairment that would require modified dosing of OS (ie, estimated creatinine clearance of ≤ 60 mL/min).
- Any condition that, in the opinion of the investigator, might compromise subject safety or interfere with evaluation of the study drug or interpretation of subject safety or study results.
Show all 25Show fewer
- History of Guillain-Barré syndrome.
- Hemagglutination antibody titer of >10 for the A/H1N1 challenge strain.
- Receipt of influenza antiviral therapy within the preceding 14 days.
- Concurrent participation in another interventional study.
- Previous receipt of an influenza mAb.
- Previous receipt of immunoglobulin or blood products within 6 months prior to screening.
- History of active infection with hepatitis B or C.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above 1.1 times the upper limit of normal (ULN) or haemoglobin, white blood cell count, or platelet count below 0.9 times the lower limit of normal at screening.
- Known immunodeficiency due to illness, including human immunodeficiency virus infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
- Note: Topical corticosteroids as prescribed by a physician for an acute, uncomplicated dermatitis may be used throughout the study; over the counter medications, including topical corticosteroids for an acute, uncomplicated dermatitis, may also be used throughout the study.
- Resides in a household with an individual who has moderate to severe immunosuppression due to illness or due to drugs.
- Note: Examples include individuals with symptomatic Acquired Immunodeficiency Syndrome; cancer and transplant patients who are taking immunosuppressive drugs; and those with inherited diseases that affect the immune system (e.g., congenital agammaglobulinemia, congenital IgA deficiency)
- History of chronic lung disease (eg, asthma/reactive airway disease and chronic obstructive pulmonary disease).
- Note: Childhood asthma that has not required treatment in adulthood is not necessarily exclusionary
- Pregnant or nursing mother.
- History of significant cardiac disease (eg, myocarditis, pericarditis, congestive heart failure, clinically significant arrhythmias).
- History of alcohol or drug abuse within the past 2 years that, according to the investigator, might affect assessments of safety or ability of subject to comply with all study requirements.
- Any planned surgical procedure before completion of Day 60.
- Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
About this study
Official title: A Phase 1/2a Clinical Study to Evaluate the Efficacy of MEDI8852 in the Treatment of Influenza in Adults Challenged With a Wild-Type Influenza Strain
The purpose of the study is to evaluate the efficacy and safety of MEDI8852 for the treatment of influenza caused by a wild type A/H1N1 challenge strain in healthy, influenza serosusceptible adults.
Read the detailed description
The study will be conducted in two parts:
Part 1:
In Part 1, eight healthy subjects, 18 to 65 years of age, will be enrolled at one study center in the United States of America (USA) and will receive a single intravenous (IV) dose of MEDI8852 (Cohort 1, dose 1) on Day 1. The subjects will be admitted to a Phase 1 unit (Day -1), for dosing (Day 1) and for follow-up (through discharge from the Phase 1 unit on Day 2). Subjects will then be followed through Day 60 for treatment emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs), treatment emergent adverse events of special interest (TEAESI), concomitant medications, nasal and blood PK, and ADA. Initiation of Part 2 of the study will be based on review of safety data from Part 1 (Days 1-8) by a study-specific Dose Evaluation Committee (DEC). For subjects in Part 1, the study is approximately 90 days in duration, consisting of a screening period of up to 30 days, a treatment period of 1 day and a follow-up period of 59 days.
Part 2:
In Part 2, approximately 60 healthy, influenza serosusceptible subjects, 18 to 65 years of age, will be enrolled at the same study center in the USA and will receive a wild-type A/H1N1 challenge strain on Day 1. Subjects will be randomized 1:1:1:1:1 into 5 cohorts (approximately 12 subjects per cohort) to receive the following on Day 2:
- Cohort 2: A single IV dose of placebo
- Cohort 3: OS, 75 mg orally BID (twice a day) for 5 days
- Cohort 4: A single IV low dose of MEDI8852 (dose 2)
- Cohort 5: A single IV high dose of MEDI8852 (dose 1)
- Cohort 6: A single IV low dose of MEDI8852 (dose 2) and oseltamivir (OS), 75 mg orally BID for 5 days
The subjects will be admitted to the Phase 1 unit (Day -1), for influenza challenge strain administration (Day 1), dosing (Day 2 [Cohorts 2, 4 and 5] and Days 2-6 [Cohorts 3 and 6]), and follow-up (through discharge from the Phase 1 unit on Day 9). Subjects will then be followed through Day 14 for solicited influenza symptoms, and through Day 60 for TEAEs, TESAEs, TEAESIs, concomitant medications, nasal and blood pharmacokinetics (PK), and antidrug antibody (ADA). For subjects in Part 2, the study is approximately 120 days in duration, consisting of a screening period of up to 60 days, a treatment period of 8 days and a follow-up period of 52 days
- Conditions
- Influenza
- Being tested
- Oseltamivir, MEDI8852, Placebo
- Keywords
- Influenza, Influenza A, Flu, Flu A
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
75 mg capsules orally twice a day from Day 2 to Day 7
MEDI8852Biological
MEDI8852 is a human IgG1 kappa monoclonal antibody administered as a single IV infusion at either dose 1 or dose 2 on Day 2.
PlaceboDrug
Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 2.
| Study group | Role | What they receive |
|---|---|---|
| MEDI8852 (dose 1) - part 1 | Experimental | Participants will receive a single intravenous infusion (IV) of MEDI8852 (dose 1) Receives: Biological: MEDI8852 |
| Placebo - part 2 | Sham comparator | Participants will received a single IV infusion of placebo ( matched to MEDI8852) on day 2 Receives: Drug: Placebo |
| Oseltamivir (OS) 75 mg - part 2 | Active comparator | Participants will receive 75 mg orally twice a day for 5 days starting at day 2 Receives: Drug: Oseltamivir |
| MEDI8852 (dose 2) - part 2 | Experimental | Participants will receive a single IV dose of MEDI8852 on day 2 (dose 2) Receives: Biological: MEDI8852 |
| MEDI8852 (dose 1) - part 2 | Experimental | Participants will receive a single IV infusion of MEDI8852 on day 2 (dose 1) Receives: Biological: MEDI8852 |
| MEDI8852 (dose 2) +OS 75 mg part 2 | Experimental | Participants will receive a single IV infusion of MEDI8852 (dose 2) on day 2 and 75mg of Oseltamivir twice a day for 5 days starting at day 2 Receives: Drug: Oseltamivir; Biological: MEDI8852 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of solicited influenza symptoms, treatment emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events of special interest (TEASIs) - part 1
To evaluate the safety and tolerability of MEDI8852 in healthy adults and influenza serosusceptible adults challenged with a wild-type A/H1N1 influenza strain
Measured: Through Day 60
Quantification of influenza viral shedding (part2) by quantitative real time polymerase chain reaction (qRT-PCR)
To evaluate the impact of MEDI8852, either when given alone or in combination with oseltamivir (OS), on nasal shedding of the A/H1N1 challenge strain in healthy, influenza serosusceptible adults, by qRT-PCR
Measured: On Days 2-9
Secondary outcomes (6)
Time to resolution of influenza symptoms
To evaluate the effect of MEDI8852, either given alone or in combination with OS, on the time to resolution of influenza symptoms in healthy, influenza serosusceptible adults challenged with a wild-type A/H1N1 influenza strain
Measured: Through Day 14
Relationship between the influenza viral shedding measured by quantitative real time polymerase chain reaction (qRT-PCR) and administered dose described by a dose-response model
To evaluate the effect of MEDI8852 administered at different dose levels on nasal shedding of the A/H1N1 challenge strain in healthy, influenza serosusceptible adults. An MCP-Mod statistical model will be fitted to the collected data to quantify the treatment effect in terms of viral shedding
Measured: Through Day 9
Incidence of solicited influenza symptoms, TEAEs, TESAEs, and TEAESIs
To evaluate the safety and tolerability of MEDI8852 in healthy, influenza serosusceptible adults challenged with a wild-type A/H1N1 influenza strain
Measured: Through Day 14 ( solicited influenza symptoms) and Through Day 60 (TEAEs, TESAEs, and TEAESIs)
MEDI8852 serum concentration
To evaluate the serum concentration of MEDI8852 in healthy adults and healthy, influenza serosusceptible adults challenged with a wild-type A/H1N1 influenza strain
Measured: Through Day 60
The incidence of Antidrug Antibody (ADA) to MEDI8852 as summarized by the number and percentage of subjects who are ADA positive by treatment group and time point
To evaluate development of ADA to MEDI8852 from baseline through the end of the study in healthy adults, and healthy, influenza serosusceptible adults challenged with a wild-type A/H1N1 influenza strain
Measured: Through Day 60
MEDI8852 nasal concentration
To evaluate the nasal concentration of MEDI8852 in healthy adults and healthy, influenza serosusceptible adults challenged with a wild-type A/H1N1 influenza strain
Measured: Through day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start3 Apr 2020 (estimated)
- Primary completion9 Oct 2020 (estimated)
- Study completion9 Oct 2020 (estimated)
Why it stopped: Terminated due to delay in site enrollment timelines
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903718
- Sponsor's protocol ID
- D6000C00004
- Status last verified
- Jan 2020
- First submitted
- 22 Mar 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Clinical Study to Evaluate the Efficacy of MEDI8852 in the Treatment of Influenza in Adults Challenged With a Wild-Type Influenza Strain
- ClinicalTrials.gov ID
- NCT03903718
- Acronym / sponsor ID
- D6000C00004
- Conditions
- Influenza
- Keywords
- Influenza, Influenza A, Flu, Flu A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to delay in site enrollment timelines
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2020 (estimated)
- Primary completion
- 9 Oct 2020 (estimated)
- Study completion
- 9 Oct 2020 (estimated)
- First posted
- 4 Apr 2019 (actual)
- 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 the study is to evaluate the efficacy and safety of MEDI8852 for the treatment of influenza caused by a wild type A/H1N1 challenge strain in healthy, influenza serosusceptible adults.
Detailed description
The study will be conducted in two parts:
Part 1:
In Part 1, eight healthy subjects, 18 to 65 years of age, will be enrolled at one study center in the United States of America (USA) and will receive a single intravenous (IV) dose of MEDI8852 (Cohort 1, dose 1) on Day 1. The subjects will be admitted to a Phase 1 unit (Day -1), for dosing (Day 1) and for follow-up (through discharge from the Phase 1 unit on Day 2). Subjects will then be followed through Day 60 for treatment emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs), treatment emergent adverse events of special interest (TEAESI), concomitant medications, nasal and blood PK, and ADA. Initiation of Part 2 of the study will be based on review of safety data from Part 1 (Days 1-8) by a study-specific Dose Evaluation Committee (DEC). For subjects in Part 1, the study is approximately 90 days in duration, consisting of a screening period of up to 30 days, a treatment period of 1 day and a follow-up period of 59 days.
Part 2:
In Part 2, approximately 60 healthy, influenza serosusceptible subjects, 18 to 65 years of age, will be enrolled at the same study center in the USA and will receive a wild-type A/H1N1 challenge strain on Day 1. Subjects will be randomized 1:1:1:1:1 into 5 cohorts (approximately 12 subjects per cohort) to receive the following on Day 2:
- Cohort 2: A single IV dose of placebo
- Cohort 3: OS, 75 mg orally BID (twice a day) for 5 days
- Cohort 4: A single IV low dose of MEDI8852 (dose 2)
- Cohort 5: A single IV high dose of MEDI8852 (dose 1)
- Cohort 6: A single IV low dose of MEDI8852 (dose 2) and oseltamivir (OS), 75 mg orally BID for 5 days
The subjects will be admitted to the Phase 1 unit (Day -1), for influenza challenge strain administration (Day 1), dosing (Day 2 [Cohorts 2, 4 and 5] and Days 2-6 [Cohorts 3 and 6]), and follow-up (through discharge from the Phase 1 unit on Day 9). Subjects will then be followed through Day 14 for solicited influenza symptoms, and through Day 60 for TEAEs, TESAEs, TEAESIs, concomitant medications, nasal and blood pharmacokinetics (PK), and antidrug antibody (ADA). For subjects in Part 2, the study is approximately 120 days in duration, consisting of a screening period of up to 60 days, a treatment period of 8 days and a follow-up period of 52 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MEDI8852 (dose 1) - part 1 | Experimental | Biological: MEDI8852Participants will receive a single intravenous infusion (IV) of MEDI8852 (dose 1) |
| Placebo - part 2 | Sham comparator | Drug: PlaceboParticipants will received a single IV infusion of placebo ( matched to MEDI8852) on day 2 |
| Oseltamivir (OS) 75 mg - part 2 | Active comparator | Drug: OseltamivirParticipants will receive 75 mg orally twice a day for 5 days starting at day 2 |
| MEDI8852 (dose 2) - part 2 | Experimental | Biological: MEDI8852Participants will receive a single IV dose of MEDI8852 on day 2 (dose 2) |
| MEDI8852 (dose 1) - part 2 | Experimental | Biological: MEDI8852Participants will receive a single IV infusion of MEDI8852 on day 2 (dose 1) |
| MEDI8852 (dose 2) +OS 75 mg part 2 | Experimental | Drug: Oseltamivir, Biological: MEDI8852Participants will receive a single IV infusion of MEDI8852 (dose 2) on day 2 and 75mg of Oseltamivir twice a day for 5 days starting at day 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 through 65 years at the time of screening.
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA, European Union [EU] Data Privacy Directive in the EU) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- For subjects enrolled in Part 1 and Part 2 of the study, agree to remain restricted to an inpatient unit until released (anticipated to be 3 days and 2 nights for Part 1 and 9 days and 8 nights for Part 2).
- Able to complete the follow-up period through Day 60 as required by the protocol.
- Female subjects of childbearing potential must also have a negative urine or blood pregnancy test at screening, on Day -1 and on and Day 1 prior to randomization
Key exclusion criteria (25 listed)
- History of allergic disease or reactions likely to be exacerbated by any component of the study drug, MEDI8852.
- For subjects enrolled in Part 2 of the study, history of allergic disease or reactions likely to be exacerbated by any component of OS.
- History of allergic disease or reactions to eggs or egg proteins
- Any fever ≥ 100.4°F (≥ 38.0°C) regardless of route of measurement and/or respiratory illness (eg, cough or sore throat) within 7 days prior to randomization.
- Renal impairment that would require modified dosing of OS (ie, estimated creatinine clearance of ≤ 60 mL/min).
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 |
|---|---|---|
| Oseltamivir75 mg capsules orally twice a day from Day 2 to Day 7 | Drug | MEDI8852 (dose 2) +OS 75 mg part 2, Oseltamivir (OS) 75 mg - part 2 |
| MEDI8852MEDI8852 is a human IgG1 kappa monoclonal antibody administered as a single IV infusion at either dose 1 or dose 2 on Day 2. | Biological | MEDI8852 (dose 1) - part 1, MEDI8852 (dose 1) - part 2, MEDI8852 (dose 2) +OS 75 mg part 2, MEDI8852 (dose 2) - part 2 |
| PlaceboPlacebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 2. | Drug | Placebo - part 2 |
Primary outcome
Incidence of solicited influenza symptoms, treatment emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events of special interest (TEASIs) - part 1
Time frame: Through Day 60
To evaluate the safety and tolerability of MEDI8852 in healthy adults and influenza serosusceptible adults challenged with a wild-type A/H1N1 influenza strain
Quantification of influenza viral shedding (part2) by quantitative real time polymerase chain reaction (qRT-PCR)
Time frame: On Days 2-9
To evaluate the impact of MEDI8852, either when given alone or in combination with oseltamivir (OS), on nasal shedding of the A/H1N1 challenge strain in healthy, influenza serosusceptible adults, by qRT-PCR
6 secondary outcomes
Time to resolution of influenza symptoms
Time frame: Through Day 14
Relationship between the influenza viral shedding measured by quantitative real time polymerase chain reaction (qRT-PCR) and administered dose described by a dose-response model
Time frame: Through Day 9
Incidence of solicited influenza symptoms, TEAEs, TESAEs, and TEAESIs
Time frame: Through Day 14 ( solicited influenza symptoms) and Through Day 60 (TEAEs, TESAEs, and TEAESIs)
MEDI8852 serum concentration
Time frame: Through Day 60
The incidence of Antidrug Antibody (ADA) to MEDI8852 as summarized by the number and percentage of subjects who are ADA positive by treatment group and time point
Time frame: Through Day 60
MEDI8852 nasal concentration
Time frame: Through day 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oseltamivir and MEDI8852 in people with Influenza, run by MedImmune LLC.
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 6 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: withdrawn, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of solicited influenza symptoms, treatment emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events of special interest (TEASIs) - part 1 (time frame: Through Day 60). The study lists 2 primary outcomes in all. 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 18 Jan 2020.