Respiratory Syncytial Virus InfectionsPhase 1NCT02114268

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

A Phase 1 study testing MEDI8897 Intravenous and MEDI8897 Intramuscular in people with Respiratory Syncytial Virus Infections, run by MedImmune LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: MEDI8897 Intravenous and MEDI8897 Intramuscular
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 342 participants
Where: 1 siteUnited States
Study dates: Apr 2014to Jun 2015
Phase: Phase 1
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 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18 through 49 years and in good health by history, physical exam, and labs
Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at Screening
Written informed consent prior to performing any protocol related procedures, including Screening evaluations
Ability to complete the Follow-up period of 360 days

Who cannot join

Acute illness including fever >= 99.5 Fahrenheit (°F) on day of dosing
Any drug therapy within 7 days prior to Day 1 (except contraceptives)
Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
Previous receipt of a monoclonal antibody (mAb)
Pregnant or nursing mother
Concurrent enrollment in another interventional study

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Overland Park, Kansas

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults

Read the detailed description

This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.

Conditions: Respiratory Syncytial Virus Infections
Being tested: MEDI8897 Intravenous, Placebo, MEDI8897 Intramuscular
Keywords: Respiratory Syncytial Virus, RSV
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI8897 IntravenousDrug
Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
PlaceboDrug
Participants received placebo on Day 1.
MEDI8897 IntravenousDrug
Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 IntravenousDrug
Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 IntramuscularDrug
Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 IntramuscularDrug
Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.

Study groups in NCT02114268
Study group	Role	What they receive
MEDI8897 300 milligram (mg) Intravenous (IV)	Experimental	Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1. Receives: Drug: MEDI8897 Intravenous
MEDI8897 1000 mg IV	Experimental	Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1. Receives: Drug: MEDI8897 Intravenous
MEDI8897 3000 mg IV	Experimental	Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1. Receives: Drug: MEDI8897 Intravenous
MEDI8897 100 mg Intramuscular (IM)	Experimental	Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1. Receives: Drug: MEDI8897 Intramuscular
MEDI8897 300 mg IM	Experimental	Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1. Receives: Drug: MEDI8897 Intramuscular
Placebo	Placebo comparator	Participants received placebo on Day 1. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
Measured: From start of study drug administration up to Day 391 (Day 361 +/- 30 days)

Secondary outcomes (7)

Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Measured: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Maximum Observed Serum Concentration (Cmax) for MEDI8897
The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Measured: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897
The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Measured: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Terminal Phase Elimination Half Life (t1/2) for MEDI8897
The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Measured: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Systemic Clearance (CL) for MEDI8897
Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Measured: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Volume of Distribution (Vz) for MEDI8897
The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).
Measured: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Number of Participants With Positive Anti-Drug Antibody (ADA)
Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.
Measured: Predose and Day 15, 31, 91, 181, 271 and 361

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jun 2015

First posted15 Apr 2014 (estimated)
Study startApr 2014
Primary completionJun 2015
Study completionJun 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Syncytial Virus InfectionsStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02114268
Sponsor's protocol ID: D5290C00001
Status last verified: Oct 2016
First submitted: 3 Apr 2014
Last updated: 28 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.
PubMed 27956428

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
ClinicalTrials.gov ID: NCT02114268
Acronym / sponsor ID: D5290C00001
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus, RSV
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 342 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 15 Apr 2014 (estimated)
Results: Posted 28 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
MEDI8897 300 milligram (mg) Intravenous (IV)	Experimental	Drug: MEDI8897 IntravenousParticipants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 1000 mg IV	Experimental	Drug: MEDI8897 IntravenousParticipants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 3000 mg IV	Experimental	Drug: MEDI8897 IntravenousParticipants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
MEDI8897 100 mg Intramuscular (IM)	Experimental	Drug: MEDI8897 IntramuscularParticipants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
MEDI8897 300 mg IM	Experimental	Drug: MEDI8897 IntramuscularParticipants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo on Day 1.

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age 18 through 49 years and in good health by history, physical exam, and labs
Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at Screening
Written informed consent prior to performing any protocol related procedures, including Screening evaluations
Ability to complete the Follow-up period of 360 days

Key exclusion criteria (6 listed)

Acute illness including fever >= 99.5 Fahrenheit (°F) on day of dosing
Any drug therapy within 7 days prior to Day 1 (except contraceptives)
Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
Previous receipt of a monoclonal antibody (mAb)
Pregnant or nursing mother

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
MEDI8897 IntravenousParticipants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.	Drug	MEDI8897 300 milligram (mg) Intravenous (IV)
PlaceboParticipants received placebo on Day 1.	Drug	Placebo
MEDI8897 IntravenousParticipants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.	Drug	MEDI8897 1000 mg IV
MEDI8897 IntravenousParticipants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.	Drug	MEDI8897 3000 mg IV
MEDI8897 IntramuscularParticipants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.	Drug	MEDI8897 100 mg Intramuscular (IM)
MEDI8897 IntramuscularParticipants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.	Drug	MEDI8897 300 mg IM

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From start of study drug administration up to Day 391 (Day 361 +/- 30 days)
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.

7 secondary outcomes

Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Maximum Observed Serum Concentration (Cmax) for MEDI8897
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Terminal Phase Elimination Half Life (t1/2) for MEDI8897
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Systemic Clearance (CL) for MEDI8897
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Volume of Distribution (Vz) for MEDI8897
Time frame: Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361
Number of Participants With Positive Anti-Drug Antibody (ADA)
Time frame: Predose and Day 15, 31, 91, 181, 271 and 361

Results and safety

Results posted to the registry on 28 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	34	28
MEDI8897 300 Milligram (mg) Intravenous (IV)	6	5
MEDI8897 1000 Milligram (mg) Intravenous (IV)	6	5
MEDI8897 3000 Milligram (mg) Intravenous (IV)	6	6
MEDI8897 100 Milligram (mg) Intramuscular (IM)	6	6
MEDI8897 300 Milligram (mg) Intramuscular (IM)	78	75

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Time frame: From start of study drug administration up to Day 391 (Day 361 +/- 30 days). Number. Unit: participants

Measure	Placebo n = 34	MEDI8897 300 Milligram (mg) Intravenous (IV) n = 6	MEDI8897 1000 Milligram (mg) Intravenous (IV) n = 6	MEDI8897 3000 Milligram (mg) Intravenous (IV) n = 6	MEDI8897 100 Milligram (mg) Intramuscular (IM) n = 6	MEDI8897 300 Milligram (mg) Intramuscular (IM) n = 78
TEAEs	21	3	3	5	4	48
TESAEs	0	0	0	0	0	2

Population analysed: The As-treated population included participants who receive any study investigational product.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Screening to Postdose Follow-up (up to 391 Days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 34 (0%)	21 of 34 (61.8%)	Not reported
MEDI8897 300 Milligram (mg) Intravenous (IV)	0 of 6 (0%)	3 of 6 (50%)	Not reported
MEDI8897 1000 Milligram (mg) Intravenous (IV)	0 of 6 (0%)	3 of 6 (50%)	Not reported
MEDI8897 3000 Milligram (mg) Intravenous (IV)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
MEDI8897 100 Milligram (mg) Intramuscular (IM)	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
MEDI8897 300 Milligram (mg) Intramuscular (IM)	2 of 78 (2.6%)	48 of 78 (61.5%)	Not reported

Limitations and caveats (from the sponsor): Physical examination parameters of participants were not evaluated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27956428Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F. Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults. Antimicrob Agents Chemother. 2017 Feb 23;61(3):e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 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.

M. Pamela Griffin, MD study director

MedImmune LLC

Martin Kankam, MD, PhD, MPH principal investigator

Study Site

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 MEDI8897 Intravenous and MEDI8897 Intramuscular in people with Respiratory Syncytial Virus Infections, 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 4 inclusion and 6 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 28 Nov 2016. 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?

Yes. Results are posted in the registry (first posted 28 Nov 2016). 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: From start of study drug administration up to Day 391 (Day 361 +/- 30 days)). 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 NCT02114268, 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 28 Nov 2016.