A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Subjects
- Sponsor
- MedImmune LLC
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: 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 Outcomes
- 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)
- Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814(Day 1, 29, 57, 85, and 106)