Safety, Tolerability, and Pharmacokinetics of AMG 827 in Adolescents With Asthma

Amgen

Status and phase: Withdrawn; Phase 1

Conditions: Asthma

Treatments: Drug: AMG 827 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395485

20101281

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and/or female subjects 12 to < 18 years of age at the time of randomization
• Male and/or female subjects between 18 and 50 years of age (inclusive) at the time of randomization
• Body weight ≥ 36 kg at screening
• Intermittent or mild to moderate persistent asthma for at least the past 3 months prior to study enrollment (as defined by the 2004 Global Initiative for Asthma [GINA] guidelines.

Exclusion criteria

• Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room or urgent care facility, or an episode treated with oral corticosteroids) during the 3 months prior to study enrollment.
• Hospitalized for asthma during the 6 months prior to study enrollment; or ever intubated for the treatment of asthma.
• Use of oral corticosteroids within 3 months prior to study enrollment.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 4 patient groups

Cohort 2

Experimental group

Description:

Adolescents - Ages 13 to \<17

Treatment:

Drug: AMG 827 or Placebo

Cohort 1

Experimental group

Description:

Adolescents - Ages 12 to \<13

Treatment:

Drug: AMG 827 or Placebo

Cohort 4

Experimental group

Description:

Adults - Ages 18 to \<=50

Treatment:

Drug: AMG 827 or Placebo

Cohort 3

Experimental group

Description:

Adolescents - Ages 17 to \<18

Treatment:

Drug: AMG 827 or Placebo