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A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL

A Phase 1 Randomized, Placebo-controlled, Dose-escalation Study to Evaluate the Safety of MEDI4212 in Subjects With IgE >= 30 IU/mL

NCT01544348•MedImmune LLC

View on ClinicalTrials.gov

Summary

Phase 1 study to evaluate the safety of MEDI4212.

Detailed Description

A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (\>=) 30 international units per milliliters (IU/mL).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age 18 through 60 years
•Written informed consent and any locally required authorization
•Body weight 45-150 kilogram (kg) for Cohorts 1-3, 4b, and 5-9. Body weight 45-90 kg for Cohort 4a
•Females must have been surgically sterilized or postmenopausal
•Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85; Both partners to use contraception
•Sterilized males must be at least 1-year post vasectomy or use a highly effective contraceptive method
•Healthy Japanese population as determined by a responsible physician
•Current diagnosis of allergic rhinitis, allergic asthma, or atopic dermatitis (cohorts 1-6) with a diagnostic immunoglobulin E (IgE) of 30 international units per milliliter (IU/mL) at Screening. Diagnostic IgE levels are further restricted for subjects enrolling into each cohort, with the following levels required at Screening: Cohorts 1 and 2: 30-700 IU/mL; Cohort 3: 30-700 IU/mL (4 subjects), greater than (\>) 700-1,200 IU/mL (4 subjects), and \>1,200 IU/mL (4 subjects); Cohort 4a: 30-500 IU/mL; Cohort 4b: \>700 IU/mL; Cohorts 5 and 6: 30-700 IU/mL (4 subjects per cohort) and \>700 IU/mL (6 subjects per cohort) or Japanese Cohorts 7-9: greater than or equal to (\>=) 30 IU/mL
•Nonsmoker for \>=6 months
•Obsolete criteria as no longer require Positive in vitro IgE fluorescence enzyme immunoassay (FEIA) response
+2 more criteria

Exclusion Criteria

•Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
•Concurrent enrollment in another clinical study
•Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
•Exposure to an anti-IgE monoclonal antibodies (MAb) within 12 months prior to Screening
•Positive drug screen at Screening or Day -1. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines
•History of regular alcohol abuse within 12 months prior to Screening
•History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation
•Subjects with abnormal liver function test values (aspartate transaminase \[AST\] and alanine transaminase \[ALT\]) at Screening as defined as follows: a) Liver function test values \>= 1.5 times upper limit of normal (ULN)
•Unwillingness or inability to follow the procedures outlined in the protocol
•Positive test or history of hepatitis B or positive hepatitis C
+10 more criteria

Locations (7)

Research Site

Cypress, California, United States

Research Site

Glendale, California, United States

Research Site

Denver, Colorado, United States

Research Site

Miami, Florida, United States

Research Site

Baltimore, Maryland, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Madison, Wisconsin, United States

Key Dates

Start Date

January 1, 2012

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

December 30, 2014

Enrollment

295

ACTUAL participants

Conditions

Allergic AsthmaAtopic DermatitisAllergic RhinitisHealthy Volunteers

Interventions

Placebo

OTHER

Omalizumab

BIOLOGICAL

MEDI4212 5 mg Subcutaneous

BIOLOGICAL

MEDI4212 15 mg Subcutaneous

BIOLOGICAL

MEDI4212 60 mg Subcutaneous

BIOLOGICAL

MEDI4212 150 mg Subcutaneous

BIOLOGICAL

MEDI4212 300 mg Subcutaneous

BIOLOGICAL

MEDI4212 300 mg Intravenous

BIOLOGICAL

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Hyper IgE Syndrome From STAT3 MutationJob s Syndrome+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

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