A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

Study Overview
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Brief Summary
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This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.

Detailed Description
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This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.

Official Title
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A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Placebo
* Biological: MEDI7814, 1 MG/KG
* Biological: MEDI7814, 3 MG/KG
* Biological: MEDI7814, 10 MG/KG
* Biological: MEDI7814, 20 MG/KG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years up to and including 49 years at the time of first dose of investigational product Healthy by medical history, physical examination, and laboratory studies Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m^2) (inclusive) Females must be of non-childbearing potential. Exclusion criteria: Any acute illness within 30 days of screening Concurrent enrollment in another clinical trial The subject has a positive drug/alcohol screen at screening or Day -1 Pregnancy Current cigarette smokers History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success Use of immunosuppressive medications Subjects who have an unresolved infection with any Neisseria species Subjects who have had their spleen removed for any reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. | Other: Placebo<br>* A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.<br>|
| Experimental: MEDI7814, 1 MG/KG<br>A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. | Biological: MEDI7814, 1 MG/KG<br>* A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.<br>|
| Experimental: MEDI7814, 3 MG/KG<br>A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. | Biological: MEDI7814, 3 MG/KG<br>* A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.<br>|
| Experimental: MEDI7814, 10 MG/KG<br>A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. | Biological: MEDI7814, 10 MG/KG<br>* A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.<br>|
| Experimental: MEDI7814, 20 MG/KG<br>A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. | Biological: MEDI7814, 20 MG/KG<br>* A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. | Day 1 to Day 106 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) Parameters of MEDI7814 | Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed. | Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106 | 
| Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814 |  | Day 1, 29, 57, 85, and 106 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subjects, MEDI7814, FTiH