Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527865
Status:
COMPLETED
Last Update Posted:
2009-01-08
First Post:
2007-09-10
Brief Title:
Single Dose Escalating Study of DAS181 in Adults
Sponsor:
Ansun Biopharma Inc
Organization:
Ansun Biopharma Inc
Study Overview
Official Title:
Study 181-1-06-01 - Phase 1A Clinical Study With DAS181 Double-Blind Randomized Placebo-Controlled Single Dose Escalating Study in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The objective of this study is to investigate the safety tolerability and pharmacokinetics of a single dose of DAS181 encapsulated dry powder compared to placebo when administered by oral inhalation using a dry powder inhaler in healthy adults Primary study outcome measures are the safety and tolerability of single-dose DAS181 treatment at 05 mg 10 mg 225 mg and 45 mg as measured in the following parameters adverse events physical exam vital signs hematology clinical chemistry blood coagulation complement activation haptoglobin and immunogenicity urinalysis throat swab for bacterial culture ECG chest X-ray and spirometric lung function Secondary outcome measures are the systemic exposure and pharmacokinetic parameters of DAS181 This phase 1 study will be a double-blind randomized placebo-controlled single-dose escalation study conducted at Comprehensive Phase One Miramar campus Thirty-six to 60 healthy male and female volunteers 18-65 years inclusive will be enrolled in 4 separate steps Each enrollment will recruit 9 subjects for one of the 4 dose groups Within each dose group the participants will be randomly assigned to placebo or DAS181 at 12 ratios The subjects will receive a single-dose treatment by placebo 105 mg lactose or by DAS181 at one of 4 doses 05 mg 10 mg 225 mg and 45 mg The subjects will be screened and enrolled within 28 days prior to dosing of the study drug The study will be initiated with 05 mg dose Escalation to the next dose will be contingent upon meeting the dose escalation criteria after the study day 7 post dosing follow-up visit Visit 4 The day of dosing is always defined as Day 0 or study day 0 regardless of the step or cohort All future visits and time periods are referenced to the day of dosing Administration of DAS181 or placebo will be given under the supervision of the study staff Subjects will enter the inpatient clinic on day -1 the evening prior to dosing Subjects will remain in the inpatient clinic for 24 hours post exposure to be observed for signs of adverse events AEs After the 24-hour inpatient observation period participants will be discharged if they are deemed healthy at that point All subjects must come back for follow-up visits on the following study days 2 7 14 1 day and 30 2 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 181-1-06-01 | None | None | None |