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Phase 1 Completed N=86 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT01544348 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) — 8; 2; 2; 1 participants

Summary

Phase 1 study to evaluate the safety of MEDI4212.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
8; 2; 2; 1; 4; 9
SECONDARY
Observed Serum Concentration
NA; 96.76; NA; NA; 254.71; 91.69
SECONDARY
Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit
0; 0; 0; 0; 1; 0
SECONDARY
Free Immunoglobulin E (IgE) Serum Concentration
1160.79; 478.99; 655.76; 601.40; 2170.63; 1976.98

Eligibility Criteria

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
  • A forced expiration volume in one second (FEV1) >= 80 percent (%) predicted in subjects with asthma. Non-asthmatic subjects with FEV1 >=80% predicted, or with FEV1 less than ( = 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
  • Positive test or history of human immunodeficiency virus (HIV) or subject is known to be HIV seropositive
  • History of cancer, with the exception of basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success
  • Women who are pregnant, breastfeeding, or lactating
  • Plans to donate blood during the study period
  • Hyper-IgE syndrome or bronchopulmonary aspergillosis
  • Prior history of Immune Complex Disease or type 3 hypersensitivity reactions to MAb administration
  • Known history of prior infusion reaction to MAb administration
  • History of untreated parasitic/helminthic infection within 6 months prior to Screening
  • Uses any of the following medications: a) Oral corticosteroids b) Medium to high dose Immunocorticosteroids (ICS)/ long-acting beta agonists (LABA) c) Immunosuppressives d) Beta blockers
  • If receiving allergy immunotherapy, must be on stable dose for 3 months. Must not receive allergy immunotherapy within 7 days of investigational product administration.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01544348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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