A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma

Pulmagen Therapeutics

Status and phase: Completed; Phase 2

Conditions: Atopic Asthma

Treatments: Drug: Placebo oral; Drug: ADC3680B oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448954

ADC3680-04

Details and patient eligibility

About

This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Partially controlled mild-moderate atopic asthma
• Receiving inhaled corticosteroids
• Non-smoker or former smoker
• Males and females aged 18 to 55 years inclusive
• If female, must be of non-childbearing potential

Exclusion criteria

• History of acute severe asthma attacks
• History of COPD
• Other serious respiratory or other medical condition which may interfere with the outcome of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

ADC3680B oral

Experimental group

Treatment:

Drug: ADC3680B oral

Placebo oral

Placebo Comparator group

Treatment:

Drug: Placebo oral