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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: FB825

• Registration Number: NCT02309762
• Lead Sponsor: Fountain Biopharma Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Study Start: 2015-03
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
FB825	FB825	6 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Composite of PK parameters	Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose	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.
Total IgE serum concentrations	pre-dose, 5, 14, 29, 85, and 140 day post-dose	Blood will be collected to measure serum IgE concentrations.
Immunogenicity (Anti-FB825 antibody in serum)	pre-dose, 5, 14, 29, 85, and 140 day post-dose	Blood will be collected to measure Immunogenicity.