SafetyPhase 1NCT02669667

Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects

A Phase 1 study testing MEDI9314 in people with Safety and Healthy Subjects, run by MedImmune LLC at 2 sites in 2 countries.

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

This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Safety, Healthy Subjects
What is being tested?: MEDI9314
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 2 sitesin 2 countries
Study dates: 18 Feb 2016to 12 Jun 2017
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Written informed consent.
Age 18 through 50 years at the time of screening.
Female subjects must be of non-childbearing potential.
Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide.
Body mass index of 19.0 through 32.0 kg/m2 at screening.
No clinically significant abnormality on the basis of medical/medication history or physical examination.

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Negative drugs of abuse (DOA).
Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
For the Japanese Cohort, both of the subject's parents and both sets of grandparents must be Japanese.

Who cannot join

Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Concurrent enrollment in another clinical study involving any treatment.
Individuals who are legally institutionalized.
Receipt of > 2 marketed or investigational biologic agents.
Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer.
Receipt of any investigational non biologic agent within 3 months or 5 half lives prior to screening, whichever is longer.

Show all 14Show fewer

Use of any medication (prescription or over the counter, including herbal remedies) within 14 days or 5 half lives of Day 1, whichever is longer, unless in the opinion of the investigator and medical monitor the medication will not interfere with the study procedures or compromise subject safety.
Known history of allergy or reaction to any component of the investigational product formulation.
History of anaphylaxis following any biologic therapy.
Any clinically relevant abnormal findings in physical examination ECG, vital signs, and laboratory parameters.
Positive tuberculosis (TB) test (QuantiFERON®-TB Gold In-tube).
Positive hepatitis B surface antigen, hepatitis C virus antibody or HIV test at screening.
Receipt of live attenuated vaccines 30 days prior to the date of screening.
Where donation of blood or blood products was in excess of 500 mL within an 8-week period in the 3 months prior to screening.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Research Site
Glendale, California, 91206

Other trials in United States

United Kingdom1 site

Research Site
Harrow, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects

This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects

Read the detailed description

This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects

Conditions: Safety, Healthy Subjects
Being tested: MEDI9314, placebo
Keywords: MEDI9314, Safety, Tolerability, Pharmacokinetics, Immunogenicity

What participants receive

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

MEDI9314Drug
single dose of MEDI9314
placeboDrug
single dose of placebo

Study groups in NCT02669667
Study group	Role	What they receive
Cohort 1	Experimental	single dose of MEDI9314 or placebo Receives: Drug: MEDI9314; Drug: placebo
Cohort 2	Experimental	single dose of MEDI9314 or placebo Receives: Drug: MEDI9314; Drug: placebo
Cohort 3	Experimental	single dose of MEDI9314 or placebo Receives: Drug: MEDI9314; Drug: placebo
Cohort 4	Experimental	single dose of MEDI9314 or placebo Receives: Drug: MEDI9314; Drug: placebo
Japanese Cohort	Experimental	single dose of MEDI9314 or placebo Receives: Drug: MEDI9314; Drug: placebo
Cohort 5	Experimental	single dose of MEDI9314 or placebo Receives: Drug: MEDI9314; 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 is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.
Measured: From the start of study drug administration upto Day 240
Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs
TEAEs observed in participants with clinically significant ECG abnormalities were reported.
Measured: From the start of study drug administration upto Day 240
Number of Participants With Vital Signs Abnormalities Reported as TEAEs
Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.
Measured: From the start of study drug administration upto Day 240
Number of Participants With Physical Examination Abnormalities Reported as TEAEs
Adverse events observed in participants with clinically significant physical abnormalities were assessed.
Measured: From the start of study drug administration upto Day 240
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Measured: From the start of study drug administration upto Day 240
Number of Participants With TEAEs Related to Injection Site Reactions
Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.
Measured: From the start of study drug administration upto Day 240

Secondary outcomes (7)

Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314
The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314.
Measured: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast)
The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314.
Measured: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314
The maximum observed serum drug concentration of MEDI9314.
Measured: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314
The time to maximum observed serum drug concentration of MEDI9314.
Measured: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Terminal Phase Elimination Half-life (t1/2) of MEDI9314
Terminal phase elimination half-life of MEDI9314
Measured: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Serum Concentrations of MEDI9314
Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed.
Measured: Baseline (Day 1 [predose]) and Day 240
Number of Participants Positive for Anti-Drug Antibodies to MEDI9314
Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented.
Measured: Baseline (Day 1 [predose]) and Day 240

Timeline

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

18 Feb 201612 Jun 2017

First posted1 Feb 2016 (estimated)
Study start18 Feb 2016
Primary completion17 Nov 2016
Study completion12 Jun 2017

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 SafetyStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02669667
Sponsor's protocol ID: D4361C00002
Status last verified: May 2019
First submitted: 20 Jan 2016
Last updated: 4 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02669667
Acronym / sponsor ID: D4361C00002
Conditions: Safety, Healthy Subjects
Keywords: MEDI9314, Safety, Tolerability, Pharmacokinetics, Immunogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: 18 Feb 2016 (actual)
Primary completion: 17 Nov 2016 (actual)
Study completion: 12 Jun 2017 (actual)
First posted: 1 Feb 2016 (estimated)
Results: Posted 15 May 2019

Clinical summary

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

This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects

Detailed description

This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort 1	Experimental	Drug: MEDI9314, Drug: placebosingle dose of MEDI9314 or placebo
Cohort 2	Experimental	Drug: MEDI9314, Drug: placebosingle dose of MEDI9314 or placebo
Cohort 3	Experimental	Drug: MEDI9314, Drug: placebosingle dose of MEDI9314 or placebo
Cohort 4	Experimental	Drug: MEDI9314, Drug: placebosingle dose of MEDI9314 or placebo
Japanese Cohort	Experimental	Drug: MEDI9314, Drug: placebosingle dose of MEDI9314 or placebo
Cohort 5	Experimental	Drug: MEDI9314, Drug: placebosingle dose of MEDI9314 or placebo

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Written informed consent.
Age 18 through 50 years at the time of screening.
Female subjects must be of non-childbearing potential.
Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide.
Body mass index of 19.0 through 32.0 kg/m2 at screening.

Key exclusion criteria (14 listed)

Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Concurrent enrollment in another clinical study involving any treatment.
Individuals who are legally institutionalized.
Receipt of > 2 marketed or investigational biologic agents.
Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer.

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
MEDI9314single dose of MEDI9314	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Japanese Cohort
placebosingle dose of placebo	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Japanese Cohort

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From the start of study drug administration upto Day 240
An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.
Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs
Time frame: From the start of study drug administration upto Day 240
TEAEs observed in participants with clinically significant ECG abnormalities were reported.
Number of Participants With Vital Signs Abnormalities Reported as TEAEs
Time frame: From the start of study drug administration upto Day 240
Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.
Number of Participants With Physical Examination Abnormalities Reported as TEAEs
Time frame: From the start of study drug administration upto Day 240
Adverse events observed in participants with clinically significant physical abnormalities were assessed.
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Time frame: From the start of study drug administration upto Day 240
An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Number of Participants With TEAEs Related to Injection Site Reactions
Time frame: From the start of study drug administration upto Day 240
Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.

7 secondary outcomes

Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314
Time frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast)
Time frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314
Time frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314
Time frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Terminal Phase Elimination Half-life (t1/2) of MEDI9314
Time frame: Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240
Serum Concentrations of MEDI9314
Time frame: Baseline (Day 1 [predose]) and Day 240
Number of Participants Positive for Anti-Drug Antibodies to MEDI9314
Time frame: Baseline (Day 1 [predose]) and Day 240

Results and safety

Results posted to the registry on 15 May 2019, 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	12	12
Cohort 1	4	4
Cohort 2	4	4
Cohort 3	6	6
Cohort 4	6	6
Cohort 5	6	5
Cohort 6	6	6

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

Time frame: From the start of study drug administration upto Day 240. Count of participants. Unit: Participants

Measure	Placebo n = 12	Cohort 1 n = 4	Cohort 2 n = 4	Cohort 3 n = 6	Cohort 4 n = 6	Cohort 5 n = 6	Cohort 6 n = 6
TEAEs	8	4	2	5	4	5	5
TESAEs	0	0	0	0	0	0	0

Population analysed: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Primary outcome: Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs

Time frame: From the start of study drug administration upto Day 240. Count of participants. Unit: Participants

Measure	Placebo n = 12	Cohort 1 n = 4	Cohort 2 n = 4	Cohort 3 n = 6	Cohort 4 n = 6	Cohort 5 n = 6	Cohort 6 n = 6
Value	0	0	0	0	0	0	0

Population analysed: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Primary outcome: Number of Participants With Vital Signs Abnormalities Reported as TEAEs

Time frame: From the start of study drug administration upto Day 240. Count of participants. Unit: Participants

Measure	Placebo n = 12	Cohort 1 n = 4	Cohort 2 n = 4	Cohort 3 n = 6	Cohort 4 n = 6	Cohort 5 n = 6	Cohort 6 n = 6
Value	0	0	0	1	0	0	0

Population analysed: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

Primary outcome: Number of Participants With Physical Examination Abnormalities Reported as TEAEs

Time frame: From the start of study drug administration upto Day 240. Count of participants. Unit: Participants

Measure	Placebo n = 12	Cohort 1 n = 4	Cohort 2 n = 4	Cohort 3 n = 6	Cohort 4 n = 6	Cohort 5 n = 6	Cohort 6 n = 6
Value	0	0	0	0	0	0	0

Population analysed: As-treated population included participants who received any study drug and summarized according to the treatment they actually received.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of study drug administration upto Day 240. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	8 of 12 (66.7%)	0 of 12
Cohort 1	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Cohort 2	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Cohort 3	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 4	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Cohort 5	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 6	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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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.

Muna Albayaty, MBChB, FFPM principal investigator

Parexel

Hakop Gevorkyan, MD principal investigator

Parexel

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI9314 in people with Safety and Healthy Subjects, run by MedImmune LLC at 2 sites in 2 countries.

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 9 inclusion and 14 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, 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. 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 15 May 2019). 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 the start of study drug administration upto Day 240). The study lists 6 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 NCT02669667.

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 4 Jun 2019.