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A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis

NCT01113034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-03-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

DAS181 dry powder, formulation F02

10 mg delivered dose DAS181 in clear HPMC #3 Capsules

DRUG

Respitose ML006 (DMV-Fonterra)

Lactose monohydrate

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Ansun Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Moss, MD · Ansun Biopharma, Inc.

  • Kenneth Olivier, MD, MPH, LCID, NIAID · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-08-22
Completion
2011-08-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01113034 on ClinicalTrials.gov