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

A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01448954

Enrollment

Registered

2011-10-07

Start date

2011-09-30

Completion date

2012-02-29

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Asthma

Brief summary

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.

Interventions

DRUGADC3680B oral

Once daily for 28 days

DRUGPlacebo oral

Once daily for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety	Baseline to Day 35
Evaluation of the change in Pulmonary function as a measure of safety and tolerability	Baseline to Day 35
Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability	Baseline to Day 28
Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability	Baseline to Day 35
Evaluation of the change in vital signs as a measure of safety	Baseline to Day 35

Secondary

Measure	Time frame
Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood	Day 1 and Day 28
Determination of concentrations of ADC3680B in plasma	Days 1-2 and Days 28-30

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026