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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002816-97-GB

Enrollment

Registered

2011-08-17

Start date

2011-09-22

Completion date

Unknown

Last updated

2012-08-28

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

Conditions

Asthma MedDRA version: 14.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: ADC3680B Product Code: ADC3680B Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AS INN Current Sponsor code: ADC3680B Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Partially controlled atopic mild-moderate subjects with asthma 2. Receiving inhaled corticosteriods 3. Non-smoker or former smoker 4. Males and females aged 18 to 55 years inclusive 5. If female, must be of non-childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. History of acute severe asthma attacks 2. History of COPD 3. Other serious respiratory or other medical condition which may interfere with the outcome of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the safety and tolerability of ADC3680B over 28 days treatment in partly controlled asthmatics;Secondary Objective: To characterise the multiple dose pharmacokinetics of ADC3680B following oral administration. Additionally, the effect of ADC3680B on exhaled nitric oxide and selected biomarkers of inflammation will be explored.;Primary end point(s): Evaluation of: Adverse events; medication use; vital signs and ECG; laboratory safety tests; spirometry and asthma symptoms (Asthma Control Questionnaire).;Timepoint(s) of evaluation of this end point: From Pre-dose and up to 7 days after IMP administration	—

Measure

Time frame

Main Objective: To investigate the safety and tolerability of ADC3680B over 28 days treatment in partly controlled asthmatics;Secondary Objective: To characterise the multiple dose pharmacokinetics of ADC3680B following oral administration. Additionally, the effect of ADC3680B on exhaled nitric oxide and selected biomarkers of inflammation will be explored.;Primary end point(s): Evaluation of: Adverse events; medication use; vital signs and ECG; laboratory safety tests; spirometry and asthma symptoms (Asthma Control Questionnaire).;Timepoint(s) of evaluation of this end point: From Pre-dose and up to 7 days after IMP administration

—

Secondary

Measure	Time frame
Secondary end point(s): Pharmacokinetics after single and multiple dose administration. Exhaled nitric oxide and selected biomarkers of inflammation will be assessed.;Timepoint(s) of evaluation of this end point: At the study start for a period of 24 hours and at study end for a period of 48 hours	—

Countries

United Kingdom

Contacts

Public ContactDirector of Clinical Development

Pulmagen Therapeutics LLP

4401753251351

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026