Single Dose Escalating Study of DAS181 in Adults

NCT00527865 | Completed Phase 1

• 2 other identifiers: 06-0082181-1-06-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability, and systemic exposure of an experimental influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is administered via oral inhalation using a special device. Study participants will include up to 60 healthy, non-smoking males and females, ages 18-65. They will be given either DAS181 or placebo. Participants will remain in the clinic overnight to be watched for health changes for 24 hours after receiving the medication. Study procedures include: physical exams, chest x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs. Follow-up visits will occur on study days 2, 7, 14 +/- 1 day, and 30 +/- 2 days. Participants will be involved in the study for up to 61 days, which includes the screening period.

Conditions

Influenza

Keywords

Influenza, Flu, DAS181, Fludase

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of a single-dose of DAS181 treatment at 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.

  Duration of study

Secondary Outcomes (1)

• The pharmacokinetic parameters of DAS181.

  Pre-dosing, 1, 2, 4, 6, 8, 12 and 24 hours post dosing, Day 2, and Day 7

Study Arms (4)

1

EXPERIMENTAL

6 subjects DAS181 dosage 0.5 mg; 3 subjects placebo

Drug: DAS181; Drug: Placebo

2

EXPERIMENTAL

6 subjects DAS181 dosage 1.0 mg; 3 subjects placebo

Drug: DAS181; Drug: Placebo

3

EXPERIMENTAL

6 subjects DAS181 dosage 2.25 mg; 3 subjects placebo

Drug: DAS181; Drug: Placebo

4

EXPERIMENTAL

6 subjects DAS181 dosage 4.5 mg; 3 subjects placebo

Drug: DAS181; Drug: Placebo

Interventions

DAS181 DRUG

DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 0.5 mg, 1.0 mg, 2.25 mg, and 4.5 mg.

1; 2; 3; 4

Placebo DRUG

Capsules containing 10.5 mg of lactose will be supplied as placebo.

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Healthy, non-smoking adult male and female volunteers between the ages of 18 and 65(inclusive)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ansun Biopharma, Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Comprehensive Phase One

Miramar, Florida, 33025, United States

Location

Related Publications (1)

• Zenilman JM, Fuchs EJ, Hendrix CW, Radebaugh C, Jurao R, Nayak SU, Hamilton RG, McLeod Griffiss J. Phase 1 clinical trials of DAS181, an inhaled sialidase, in healthy adults. Antiviral Res. 2015 Nov;123:114-9. doi: 10.1016/j.antiviral.2015.09.008. Epub 2015 Sep 25.

  PMID: 26391974 DERIVED

Related Links

• NexBio, Inc

MeSH Terms

Conditions

Influenza, Human

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 8, 2009

Record last verified: 2009-01

Locations

US (1)