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OpenTrials
Completed

NCT Number: NCT02309762

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

FB825

Drug

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

Placebo

Drug

Solution containing no active ingredients

Primary outcomes

  1. Number of Participants with Adverse events (AE)

    Time frame: Up to day140

  2. Clinical laboratory test results (hematology, coagulation, serum chemistry[including liver function tests], and urinalysis)

    Time frame: Up to day140

  3. Vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and oral body temperature)

    Time frame: Up to day140

  4. 12-lead ECG results

    Time frame: Up to day140

  5. Physical examination findings

    Time frame: Up to day140

Secondary outcomes

  1. Composite of PK parameters

    Time frame: 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.

  2. Total IgE serum concentrations

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

    Blood will be collected to measure serum IgE concentrations.

  3. Immunogenicity (Anti-FB825 antibody in serum)

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

    Blood will be collected to measure Immunogenicity.

Sponsors and collaborators

Lead sponsor

Fountain Biopharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2014
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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