Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528

NCT00116168 | Completed Phase 1 Results

• 1 other identifier: MI-CP109
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Incidence of Adverse Events

  Number of participants experiencing adverse events (includes both adverse events and serious adverse events)

  Days 0 - 84

• Incidence of Abnormal Troponin Levels

  Number of participants with troponin levels greater than upper limit of normal

  Days 0, 1, 7, 14, and 28

• Incidence of Clinically Significant Changes From Baseline in Neurologic Exam

  Number of participants with clinically significant changes from baseline in neurologic exam

  Days 0, 7, 14, 21, 28, 42, and 84

• Incidence of Changes From Baseline in the Day 28 Magnetic Resonance Imaging (MRI) of the Brain

  Number of participants with changes from baseline in the Day 28 MRI of the brain

  Days 0 and 28

• Incidence of Serious Adverse Events

  Number of participants experiencing serious adverse events

  Days 0 - 84

Secondary Outcomes (9)

• Incidence of Anti-drug Antibodies (ADA) to MEDI-528

  Days 0, 14, 28, 42, and 84

• Time to Observed Maximum Serum Concentration (Tmax)

  Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84

• Observed Maximum Serum Concentration (Cmax)

  Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84

• Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]

  Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84

• Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] of MEDI-528

  Days 0, 1, 2, 3, 4, 5, 7, 10, 14, 21, 28, 42, and 84

Study Arms (4)

MEDI-528 0.3 mg/kg

EXPERIMENTAL

MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose

Biological: MEDI-528 0.3 mg/kg

MEDI-528 1 mg/kg

EXPERIMENTAL

MEDI-528 (1 mg/kg) administered as a single, SC dose

Biological: MEDI-528 1 mg/kg

MEDI-528 3 mg/kg

EXPERIMENTAL

MEDI-528 (3 mg/kg) administered as a single, SC dose

Biological: MEDI-528 3 mg/kg

MEDI-528 9 mg/kg

EXPERIMENTAL

MEDI-528 (9 mg/kg) administered as a single, SC dose

Biological: MEDI-528 9 mg/kg

Interventions

MEDI-528 0.3 mg/kg BIOLOGICAL

MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose

MEDI-528 0.3 mg/kg

MEDI-528 1 mg/kg BIOLOGICAL

MEDI-528 (1 mg/kg) administered as a single, SC dose

MEDI-528 1 mg/kg

MEDI-528 3 mg/kg BIOLOGICAL

MEDI-528 (3 mg/kg) administered as a single, SC dose

MEDI-528 3 mg/kg

MEDI-528 9 mg/kg BIOLOGICAL

MEDI-528 (9 mg/kg) administered as a single, SC dose

MEDI-528 9 mg/kg

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females age 19 up to, and including, 49 years of age at the time of the first dose of study drug
• Weight less than 89 kg
• Written informed consent obtained from the volunteer
• Healthy by medical history and physical examination
• Sexually active females, unless surgically sterile or at least two years post-menopausal or an FSH≥40 mIu/mL, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions through the study period of 84 days. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through Study Day 84 after their dose of study drug.
• Use of common over-the-counter medications such as topical corticosteroids, decongestants, antihistamines, analgesics, and antacids is permitted unless, in the opinion of the investigator, it would interfere with either the volunteer's ability to complete the study or interpretation of the study results.
• Ability to complete the follow-up period of 84 days
• Willing to forego other forms of experimental treatment during the study period of 84 days
• Willing to forego vigorous activity 1 - 2 days before dosing, and before each study visit.

You may not qualify if:

• Acute illnesses or evidence of significant active infection, such as fever greater than or equal to 38.0 C (100.5°F) at the start of the study
• Use of prescription medications, other than oral contraceptives, in the 28-day period before Study Day 0
• Any blood donation or significant loss of blood within 6 months of time of entry into the study
• History of immunodeficiency or receipt of immunosuppressive drugs
• History of allergy or reaction to any component of the MEDI-528 formulation
• History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period
• Evidence of any systemic disease, neurologic abnormality, lymphadenopathy, or splenomegaly upon physical examination
• Evidence of infection with hepatitis A, B, or C virus or HIV-1
• Receipt of immunoglobulins or blood products within 60 days of entering the study
• Receipt of any investigational drug therapy or standard vaccine therapy, other than vaccination for influenza, within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)
• Receipt of MEDI-528 in any previous clinical study
• At Screening (must be within 21 days before study dose administration) any of the following: Hgb, total WBC, platelet count, Na, K, C1, CO2, AST, ALT, BUN, glucose, amylase, lipase, creatinine, or troponin out of the normal range; other abnormal laboratory values in the screening panel that, in the opinion of the principal investigator, are judged to be clinically significant
• Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram at the time of initial screening
• Clinically significant abnormalities noted on baseline brain MRI
• Elective surgery planned during the study period through Study Day 84

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (2)

MDS Pharma Services

New Orleans, Louisiana, 70119, United States

Location

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

• White B, Leon F, White W, Robbie G. Two first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers. Clin Ther. 2009 Apr;31(4):728-40. doi: 10.1016/j.clinthera.2009.04.019.

  PMID: 19446146 DERIVED

MeSH Terms

Interventions

enokizumab

Results Point of Contact

• Title: Don Raible, MD
• Organization: MedImmune

raibleD@medimmune.com

301-398-0000

Study Officials

• Barbara White, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2005
• First Posted: June 28, 2005
• Study Start: June 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: July 1, 2006
• Last Updated: December 11, 2013
• Results First Posted: December 11, 2013

Record last verified: 2013-10

Locations

US (2)