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

Phase 1

Completed

Interventions: Biological: MEDI7814, 1 MG/KG
Other: Placebo
Biological: MEDI7814, 10 MG/KG
Biological: MEDI7814, 20 MG/KG
Biological: MEDI7814, 3 MG/KG

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
MEDI7814, 1 MG/KG	MEDI7814, 1 MG/KG	A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
Placebo	Placebo	A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 10 MG/KG	MEDI7814, 10 MG/KG	A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 20 MG/KG	MEDI7814, 20 MG/KG	A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 3 MG/KG	MEDI7814, 3 MG/KG	A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	Day 1 to Day 106	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameters of MEDI7814	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	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.
Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814	Day 1, 29, 57, 85, and 106