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 range

12 Years – 50 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Throughout the study duration

Trial details

NCT IDNCT01137565

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-01

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range

12 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.