A Single Dose Study to Determine the Safety and Pharmacokinetics of FP01 Lozenges in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: FP01

• Registration Number: NCT01579526
• Lead Sponsor: Avalo Therapeutics, Inc.

Brief Summary

The purpose of this study is to determine the safety and pharmacokinetics of FP01 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-04
• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-18
• Status Verified: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FP01 Dose 1	FP01	Drug
FP01 Dose 2	FP01	Drug
FP01 Dose 3	FP01	Drug
Comparator	FP01	Drug

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic profiles of the active pharmaceutical ingredient	various timepoints over 72 hours	Plasma PK profiles: various PK indices including, but not limited to, peak plasma concentration (Cmax), Area under the plasma concentration versus time curve (AUC), and elimination half-life (T1/2), and time to peak plasma concentration (Tmax).
Safety and Tolerability	Various Timepoints over 72 Hours	Safety and Tolerability will take into account the recorded AEs, vital signs, and clinical and laboratory assessments.

Trial Locations

Locations (1)

Prism Research; 🇺🇸 Saint Paul, Minnesota, United States