Healthy VolunteerPhase 1NCT02151110
Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
A Phase 1 study testing MEDI4920 3 mg, MEDI4920 10 mg and MEDI4920 30 mg in people with Healthy Volunteer, run by MedImmune LLC at 1 site in United Kingdom.
Trial summary
Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920 Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MEDI4920 3 mg, MEDI4920 10 mg and MEDI4920 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2014to 9 May 2016
- 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
- Healthy as determined by a responsible study physician based on medical evaluation
- Body weight 40 to 100 kg
- Body mass index 19.0 to 30.0 kg/m2
Who cannot join
- History of allergy or sensitivity to Shellfish or protein based antigens
- previous immunization with KLH
- previous splenectomy
- History of diagnosed or suspected thromboembolic event or coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults
Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
- Conditions
- Healthy Volunteer
- Being tested
- MEDI4920 3 mg, MEDI4920 10 mg, MEDI4920 30 mg, MEDI4920 100 mg, MEDI4920 300 mg
- Keywords
- Healthy Male, Healthy Female of non child bearing potential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI4920 3 mgBiological
Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
MEDI4920 10 mgBiological
Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
MEDI4920 30 mgBiological
Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
MEDI4920 100 mgBiological
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
MEDI4920 300 mgBiological
Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
MEDI4920 1000 mgBiological
Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
MEDI4920 3000 mgBiological
Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
PlaceboOther
Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. Receives: Other: Placebo |
| MEDI4920 3 mg | Experimental | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. Receives: Biological: MEDI4920 3 mg |
| MEDI4920 10 mg | Experimental | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. Receives: Biological: MEDI4920 10 mg |
| MEDI4920 30 mg | Experimental | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. Receives: Biological: MEDI4920 30 mg |
| MEDI4920 100 mg | Experimental | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. Receives: Biological: MEDI4920 100 mg |
| MEDI4920 300 mg | Experimental | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. Receives: Biological: MEDI4920 300 mg |
| MEDI4920 1000 mg | Experimental | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. Receives: Biological: MEDI4920 1000 mg |
| MEDI4920 3000 mg | Experimental | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. Receives: Biological: MEDI4920 3000 mg |
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 any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.
Measured: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit
Secondary outcomes (10)
Maximum Observed Plasma Concentration (Cmax) of MEDI4920
The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920
The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920
The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI4920 dose. The AUC (0-infinity)/D was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Terminal Elimination Half Life (t1/2) of MEDI4920
The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Systemic Clearance (CL) of MEDI4920
The systemic clearance (CL) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Volume of Distribution at Steady-state (Vss) of MEDI4920
The volume of distribution at steady-state (Vss) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920
The volume of distribution based on terminal phase (Vz) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.
Measured: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Percentage of Participants Positive for Anti-drug Antibodies (ADA)
Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented.
Measured: Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first
T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration
The T-cell dependent antibody response (TDAR) assay measures the immune response (ie, antibody production) to an introduced antigen, keyhole limpet hemocyanin (KLH). The KLH is a potent immunostimulating protein with an extensive history of safe and effective use in vaccine development and immunological research. TDAR was evaluated by measuring anti-KLH IgG titers at a time point consistent with the expected timing for antibody responses following immunization. The primary time point for the analysis of the TDAR to KLH was Day 43. The data was presented for geometric mean ratio (MEDI4920/placebo) estimated from the dose response model.
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start27 May 2014
- Primary completion9 May 2016
- Study completion9 May 2016
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 Healthy VolunteerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 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
- NCT02151110
- Sponsor's protocol ID
- D5100C00001
- Status last verified
- Sep 2018
- First submitted
- 27 May 2014
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults
- ClinicalTrials.gov ID
- NCT02151110
- Acronym / sponsor ID
- D5100C00001
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Male, Healthy Female of non child bearing potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 27 May 2014 (actual)
- Primary completion
- 9 May 2016 (actual)
- Study completion
- 9 May 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
| MEDI4920 3 mg | Experimental | Biological: MEDI4920 3 mgParticipants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
| MEDI4920 10 mg | Experimental | Biological: MEDI4920 10 mgParticipants received single IV dose of MEDI4920 10 mg infused on Day 1. |
| MEDI4920 30 mg | Experimental | Biological: MEDI4920 30 mgParticipants received single IV dose of MEDI4920 30 mg infused on Day 1. |
| MEDI4920 100 mg | Experimental | Biological: MEDI4920 100 mgParticipants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| MEDI4920 300 mg | Experimental | Biological: MEDI4920 300 mgParticipants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| MEDI4920 1000 mg | Experimental | Biological: MEDI4920 1000 mgParticipants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| MEDI4920 3000 mg | Experimental | Biological: MEDI4920 3000 mgParticipants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy as determined by a responsible study physician based on medical evaluation
- Body weight 40 to 100 kg
- Body mass index 19.0 to 30.0 kg/m2
Key exclusion criteria (4 listed)
- History of allergy or sensitivity to Shellfish or protein based antigens
- previous immunization with KLH
- previous splenectomy
- History of diagnosed or suspected thromboembolic event or coagulation disorder
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 |
|---|---|---|
| MEDI4920 3 mgParticipants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. | Biological | MEDI4920 3 mg |
| MEDI4920 10 mgParticipants received single IV dose of MEDI4920 10 mg infused on Day 1. | Biological | MEDI4920 10 mg |
| MEDI4920 30 mgParticipants received single IV dose of MEDI4920 30 mg infused on Day 1. | Biological | MEDI4920 30 mg |
| MEDI4920 100 mgParticipants received single IV dose of MEDI4920 100 mg infused on Day 1. | Biological | MEDI4920 100 mg |
| MEDI4920 300 mgParticipants received single IV dose of MEDI4920 300 mg infused on Day 1. | Biological | MEDI4920 300 mg |
| MEDI4920 1000 mgParticipants received single IV dose of MEDI4920 1000 mg infused on Day 1. | Biological | MEDI4920 1000 mg |
| MEDI4920 3000 mgParticipants received single IV dose of MEDI4920 3000 mg infused on Day 1. | Biological | MEDI4920 3000 mg |
| PlaceboParticipants received single IV dose of placebo matching with MEDI4920 infused on Day 1. | Other | Placebo |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit
An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.
10 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Terminal Elimination Half Life (t1/2) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Systemic Clearance (CL) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Volume of Distribution at Steady-state (Vss) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920
Time frame: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first
Percentage of Participants Positive for Anti-drug Antibodies (ADA)
Time frame: Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first
T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration
Time frame: Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 MEDI4920 3 mg, MEDI4920 10 mg and MEDI4920 30 mg in people with Healthy Volunteer, run by MedImmune LLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 Feb 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: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit). 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 15 Feb 2019.