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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01544361

CD-RI-MEDI7814-1027

Details and patient eligibility

About

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

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.

Treatment:

Other: Placebo

MEDI7814, 1 MG/KG

Experimental group

Description:

A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.

Treatment:

Biological: MEDI7814, 1 MG/KG

MEDI7814, 3 MG/KG

Experimental group

Description:

A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Treatment:

Biological: MEDI7814, 3 MG/KG

MEDI7814, 10 MG/KG

Experimental group

Description:

A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Treatment:

Biological: MEDI7814, 10 MG/KG

MEDI7814, 20 MG/KG

Experimental group

Description:

A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Treatment:

Biological: MEDI7814, 20 MG/KG