A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis

NCT01113034 Phase 1 COMPLETED

The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled asthma or bronchiectasis.

Details

Lead sponsor	Ansun Biopharma, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	11
Start date	2010-07
Completion	2011-08-22

Conditions

• Asthma
• Bronchiectasis

Interventions

• DAS181 dry powder, formulation F02
• Respitose ML006 (DMV-Fonterra)

Primary outcomes

• Safety and toxicity profile: Unacceptable Serious Adverse Events — 6 weeks (up to 12 weeks)

Countries

United States