Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers

NCT00192296 | Completed Phase 1 Results

• 1 other identifier: MI-CP105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• 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 (\> 0.05 ng/mL)

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

• Time to Observed Maximum Serum Concentration (Tmax)

  Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84

• Observed Maximum Serum Concentration (Cmax)

  Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 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 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84

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

  Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 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, intravenous (IV) dose

Biological: MEDI-528 0.3 mg/kg

MEDI-528 1 mg/kg

EXPERIMENTAL

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

Biological: MEDI-528 1 mg/kg

MEDI-528 3 mg/kg

EXPERIMENTAL

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

Biological: MEDI-528 3 mg/kg

MEDI-528 9 mg/kg

EXPERIMENTAL

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

MEDI-528 0.3 mg/kg

MEDI-528 1 mg/kg BIOLOGICAL

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

MEDI-528 1 mg/kg

MEDI-528 3 mg/kg BIOLOGICAL

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

MEDI-528 3 mg/kg

MEDI-528 9 mg/kg BIOLOGICAL

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

MEDI-528 9 mg/kg

Eligibility Criteria

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

You may qualify if:

• Males and females age 18 up to and including 49 years of age at the time of the first dose of study drug
• Weight \< 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 one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap,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 84 days after their dose of study drug. 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 84 days 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 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

You may not qualify if:

• Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C (100.5°F) at the start of the study
• Use of prescription medications, other than contraceptives, in the 28-day period before Study Day 0
• Blood donation in excess of 400 mL within 6 months of the time of entry into the study
• History of use of tobacco products within 3 years of Study Day 0 or history of smoking of \>10 pack-years
• History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids
• History of allergic disease or reactions likely to be exacerbated by any component of the Study Drug (described in the Investigator's Brochure)
• 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 on 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 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)
• Any of the following: CBC: Hgb \< 12.0 gm/dL; WBC \< 4,000/mm3; platelet count \<125,000/mm3 (or laboratory normal values); Na, K, Cl, CO2, AST, ALT, BUN, 4-hour fasting glucose, amylase, lipase, creatinine, troponin \> upper limit of normal; other abnormal laboratory values in the screening panel which 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
• Elective surgery planned during the study period through Study Day 84
• Pregnancy (sexually active females must have a negative serum pregnancy test on the day of the first dose of the study drug, before dosing)

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

MDS Pharma Services

New Orleans, Louisiana, 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

Conditions

Asthma

Interventions

enokizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Joseph Parker, MD
• Organization: MedImmune

parkerj@medimmune.com

301-398-0000

Study Officials

• Ramon Vargas, MD

  PRINCIPAL INVESTIGATOR

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: September 12, 2005
• First Posted: September 19, 2005
• Study Start: August 1, 2004
• Primary Completion: February 1, 2005
• Study Completion: March 1, 2005
• Last Updated: March 6, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-02

Locations

US (1)