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

NCT01544361 | Completed Phase 1 Results

• 1 other identifier: CD-RI-MEDI7814-1027
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Healthy subjects; MEDI7814; FTiH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

MEDI7814, 1 MG/KG

EXPERIMENTAL

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

MEDI7814, 3 MG/KG

EXPERIMENTAL

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

Biological: MEDI7814, 3 MG/KG

MEDI7814, 10 MG/KG

EXPERIMENTAL

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

Biological: MEDI7814, 10 MG/KG

MEDI7814, 20 MG/KG

EXPERIMENTAL

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

Biological: MEDI7814, 20 MG/KG

Interventions

Placebo OTHER

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

Placebo

MEDI7814, 1 MG/KG BIOLOGICAL

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

MEDI7814, 1 MG/KG

MEDI7814, 3 MG/KG BIOLOGICAL

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

MEDI7814, 3 MG/KG

MEDI7814, 10 MG/KG BIOLOGICAL

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

MEDI7814, 10 MG/KG

MEDI7814, 20 MG/KG BIOLOGICAL

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

MEDI7814, 20 MG/KG

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Omaha, Nebraska, United States

Location

Limitations and Caveats

Analyses of PK parameters and immunogenicity were not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.

Results Point of Contact

• Title: Joseph M. Parker, Director, Clinical Development
• Organization: MedImmune, LLC.

parkerj@medimmune.com

301-398-0000

Study Officials

• Alan Marion, MD

  Research site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: March 5, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 23, 2014
• Results First Posted: July 23, 2014

Record last verified: 2014-06

Locations

US (1)