A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB825 in Healthy Volunteers

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Ascending Intravenous Doses of FB825

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: FB825; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject is male or female between 18 and 55 years of age, inclusive.
2. All female subjects must have a negative serum pregnancy test at screening and on Day -1.
3. The subject has a body weight ≥50 kg at screening and a body mass index of 18 to 30 kg/m2, inclusive.
4. The subject has a good health condition based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
5. The subject has a negative urine drug screen for alcohol, cotinine.

Exclusion Criteria:

1. Female subjects who are pregnant or lactating.
2. The subject has a past history of heart arrhythmias.
3. The subject has history of clinically significant diseases.
4. The subject has any history of a previous anaphylactic reaction.
5. Use of prescribed medication within 6 months of Day -1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Solution containing no active ingredients
Experimental: FB825; 6 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg	Drug: FB825; FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse events (AE)	Up to day140
Clinical laboratory test results (hematology, coagulation, serum chemistry[including liver function tests], and urinalysis)	Up to day140
Vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and oral body temperature)	Up to day140
12-lead ECG results	Up to day140
Physical examination findings	Up to day140

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of PK parameters	Blood will be collected for the determination of serum FB825 concentrations, Cmax, Tmax, AUC, and terminal half-life.These parameters will be determined using non-compartmental methods.	Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose
Total IgE serum concentrations	Blood will be collected to measure serum IgE concentrations.	pre-dose, 5, 14, 29, 85, and 140 day post-dose
Immunogenicity (Anti-FB825 antibody in serum)	Blood will be collected to measure Immunogenicity.	pre-dose, 5, 14, 29, 85, and 140 day post-dose

Collaborators and Investigators

• Sponsor: Fountain Biopharma Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: FB825CLCT01