EUCTR2011-005503-33-PL
Active, not recruiting
Not Applicable
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents with Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MedImmune Ltd
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 12\-17 years (inclusive)
- •Weight \> 30kg
- •Asthma for a minimum of 6 months
- •Effective birth control for both male and female participants in line with protocol details.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Previously taken tralokinumab (the study drug)
- •Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals.
- •Pregnant or breastfeeding women
- •Current smoker or cessation \< 3 months
- •Known immune deficiency
- •History of cancer
- •Hepatitis B, C or HIV
- •Any disease which may cause complications whilst taking the study drug
Outcomes
Primary Outcomes
Not specified
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