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

NCT02309762 | Completed Phase 1 DMC

• 1 other identifier: FB825CLCT01
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Composite of PK parameters

  Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose

• Total IgE serum concentrations

  pre-dose, 5, 14, 29, 85, and 140 day post-dose

• Immunogenicity (Anti-FB825 antibody in serum)

  pre-dose, 5, 14, 29, 85, and 140 day post-dose

Study Arms (2)

FB825

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

FB825 DRUG

FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection

FB825

Placebo DRUG

Solution containing no active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fountain Biopharma Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: December 5, 2014
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 4, 2016

Record last verified: 2016-02