Safety, Tolerability, and Pharcodynamics of AMG 853 in Adolescents With Asthma (NCT01137565) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Pharcodynamics of AMG 853 in Adolescents With Asthma
23 participantsStarted 2010-06
Plain-language summary
The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.
Who can participate
Age range12 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and/or female subjects ≥12 to \< 18 years of age (for Cohorts 1, 2, and 3 as indicated in the study design).
* Male and/or non-reproductive female subjects between 18 and 50 years of age, inclusive (for cohort 4).
* Females of non-reproductive potential must have documented medical history (ie, postmenopausal by history - no menses for 1 year - and follicle-stimulating hormone value (FSH) consistent with postmenopausal status per laboratory ranges; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
* Females of child-bearing potential and females who cannot document non-reproductive potential must agree to use highly effective methods of birth control for the duration of the study and for 2 weeks after study drug administration. Males whose partners are of child bearing potential must agree to use highly effective methods of birth control for the duration of the study and continuing for 12 weeks after study drug administration. Highly effective methods of birth control (i.e., those with a failure rate of less than 1% per year) include sexual abstinence (males, females), vasectomy or a condom supplemented with the use of a spermicide (males) and occlusive cap (diaphragm or cervical/vault caps), hormonal birth control, or intrauterine device (IUD) used by the female partner.
* Male subjects whose partners become pregnant during the study must practice sexual abstinence or use a condom with sperm…
What they're measuring
1
Evaluation of treatment-emergent adverse events, safety and laboratory assessments in adolescent subjects with intermittent or mild to moderate asthma as a measure of safety and tolerability