Clinical trial NCT02151110: Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
Official title: A Phase 1, Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Male
Healthy Female of non child bearing potential
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of MEDI4920
timeFrame: 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
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920
timeFrame: 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
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920
timeFrame: 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
measure: Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920
timeFrame: 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
measure: Terminal Elimination Half Life (t1/2) of MEDI4920
timeFrame: 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
measure: Systemic Clearance (CL) of MEDI4920
timeFrame: 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
measure: Volume of Distribution at Steady-state (Vss) of MEDI4920
timeFrame: 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
measure: Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920
timeFrame: 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
measure: Percentage of Participants Positive for Anti-drug Antibodies (ADA)
timeFrame: Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first
measure: T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration
timeFrame: Day 43
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Research Site
Study officials:
References: