InfluenzaPhase 1MEDI8852NCT02350751
Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults
A Phase 1 study testing MEDI8852 in people with Influenza, run by MedImmune LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. 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?
- MEDI8852
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 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 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
- Weight ≥ 45 kg and ≤ 110 kg at screening
- Healthy by medical history, physical examination, and baseline safety laboratory studies.
- Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening
- Electrocardiogram without clinically significant abnormalities at screening
- Able to complete the follow-up period through Day 101 as required by the protocol
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 28 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study
Who cannot join
- Acute illness, including fever > 99.5°F, on day prior to or day of planned dosing
- Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine. and other nutritional supplements that have not been taken for at least 30 days prior to enrollment, are not exclusionary.
- Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
- Receipt of immunoglobulin or blood products within 6 months prior to screening
- Receipt of any vaccine within 14 days prior to investigational product dosing or planned receipt of any influenza vaccine within 100 days after investigational product dosing
- Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening
Show all 10Show fewer
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above the upper limit of normal or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening
- History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years
- Pregnant or nursing mother
- History of alcohol or drug abuse within the past 2 years tha OR positive Class A drug screen for amphetamines, barbiturates, opiates, or cocaine at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-blind, Single-dose, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults
The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects.
Read the detailed description
This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV). A total of 4 different dose levels of investigational product will be evaluated across the cohorts. Subjects will be followed for approximately 100 days.
- Conditions
- Influenza
- Being tested
- MEDI8852, Placebo
- Keywords
- Influenza, Flu, Flu A, Influenza 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.
MEDI8852Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MEDI8852 | Experimental | MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) supplied as 50 mg/mL solution for infusion. MEDI8852 is being evaluated for treatment of patients hospitalized with influenza A. Receives: Drug: MEDI8852 |
| Placebo | Placebo comparator | Solution containing no active ingredients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.
Measured: 100 days postdose
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)
Measured: 28 days postdose
Secondary outcomes (6)
Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Measured: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allows.
Measured: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Measured: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: area under the concentration time curve from 0 to t (AUC 0-t) and from 0 to infinity (AUC 0-inf)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Measured: 100 days postdose
Incidence of anti-drug antibody to MEDI8852 in serum
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Measured: 100 days postdose
Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss)
This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
Measured: 100 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 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
- NCT02350751
- Sponsor's protocol ID
- D6000C00001
- Acronym
- MEDI8852
- Status last verified
- Jul 2015
- First submitted
- 23 Dec 2014
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mallory RM, Ali SO, Takas T, Kankam M, Dubovsky F, Tseng L. A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers. Biologicals. 2017 Nov;50:81-86. doi: 10.1016/j.biologicals.2017.08.007. Epub 2017 Aug 23.
PubMed 28844541
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Single-dose, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults
- ClinicalTrials.gov ID
- NCT02350751
- Acronym / sponsor ID
- MEDI8852 / D6000C00001
- Conditions
- Influenza
- Keywords
- Influenza, Flu, Flu A, Influenza A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jan 2015 (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 evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects.
Detailed description
This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV). A total of 4 different dose levels of investigational product will be evaluated across the cohorts. Subjects will be followed for approximately 100 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI8852 | Experimental | Drug: MEDI8852MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) supplied as 50 mg/mL solution for infusion. MEDI8852 is being evaluated for treatment of patients hospitalized with influenza A. |
| Placebo | Placebo comparator | Drug: PlaceboSolution containing no active ingredients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 through 65 years at the time of screening
- Weight ≥ 45 kg and ≤ 110 kg at screening
- Healthy by medical history, physical examination, and baseline safety laboratory studies.
- Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening
- Electrocardiogram without clinically significant abnormalities at screening
Key exclusion criteria (10 listed)
- Acute illness, including fever > 99.5°F, on day prior to or day of planned dosing
- Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine. and other nutritional supplements that have not been taken for at least 30 days prior to enrollment, are not exclusionary.
- Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
- Receipt of immunoglobulin or blood products within 6 months prior to screening
- Receipt of any vaccine within 14 days prior to investigational product dosing or planned receipt of any influenza vaccine within 100 days after investigational product dosing
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 |
|---|---|---|
| MEDI8852 | Drug | MEDI8852 |
| Placebo | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
Time frame: 100 days postdose
Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852
Time frame: 28 days postdose
Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)
6 secondary outcomes
Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½)
Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL)
Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax)
Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum: area under the concentration time curve from 0 to t (AUC 0-t) and from 0 to infinity (AUC 0-inf)
Time frame: 100 days postdose
Incidence of anti-drug antibody to MEDI8852 in serum
Time frame: 100 days postdose
Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss)
Time frame: 100 days postdose
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 13 Jul 2015.
- Derived from this study: PubMed 28844541Mallory RM, Ali SO, Takas T, Kankam M, Dubovsky F, Tseng L. A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers. Biologicals. 2017 Nov;50:81-86. doi: 10.1016/j.biologicals.2017.08.007. Epub 2017 Aug 23.
Related trials for Influenza
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
RecruitingPhase 1
A Trial to Evaluate the Effect of CD388/MK1406 on the Immunogenicity of Fluzone® HD Vaccine (CD388.SQ.1.08/MK-1406-007)
Healthy Participants
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
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 MEDI8852 in people with Influenza, run by MedImmune LLC 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 7 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 13 Jul 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?
Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852 (time frame: 100 days postdose). 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?
On the ClinicalTrials.gov record for NCT02350751, 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 13 Jul 2015.