Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
A Phase 1, Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults
1 other identifier
interventional
59
1 country
1
Brief Summary
Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2014
CompletedStudy Start
First participant enrolled
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2016
CompletedResults Posted
Study results publicly available
February 15, 2019
CompletedFebruary 15, 2019
September 1, 2018
2 years
May 27, 2014
May 24, 2017
October 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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
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
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
- +5 more secondary outcomes
Study Arms (8)
Placebo
PLACEBO COMPARATORParticipants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
MEDI4920 3 mg
EXPERIMENTALParticipants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
MEDI4920 10 mg
EXPERIMENTALParticipants received single IV dose of MEDI4920 10 mg infused on Day 1.
MEDI4920 30 mg
EXPERIMENTALParticipants received single IV dose of MEDI4920 30 mg infused on Day 1.
MEDI4920 100 mg
EXPERIMENTALParticipants received single IV dose of MEDI4920 100 mg infused on Day 1.
MEDI4920 300 mg
EXPERIMENTALParticipants received single IV dose of MEDI4920 300 mg infused on Day 1.
MEDI4920 1000 mg
EXPERIMENTALParticipants received single IV dose of MEDI4920 1000 mg infused on Day 1.
MEDI4920 3000 mg
EXPERIMENTALParticipants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Interventions
Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (1)
Research Site
Leeds, LS2 9LH, United Kingdom
Results Point of Contact
- Title
- David Howe, MBChB, MD, MRCOG
- Organization
- MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2014
First Posted
May 30, 2014
Study Start
May 27, 2014
Primary Completion
May 9, 2016
Study Completion
May 9, 2016
Last Updated
February 15, 2019
Results First Posted
February 15, 2019
Record last verified: 2018-09