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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544361
• Other study ID #: CD-RI-MEDI7814-1027
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2012
• Last updated: June 23, 2014
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: June 2014
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Biological:
• MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.
• MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
• 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
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Locations

Country	Name	City	State
United States	Research Site	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814		Day 1, 29, 57, 85, and 106	No