Safety and Pharmacokinetics Study of FBF001

Avian Influenza Clinical Trial

Official title:

A Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of One Single Intravenous Dose and 5-day Repeated Intravenous Doses of FBF001 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295813
• Other study ID #: 201101H-TOLPKE
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2014
• Last updated: November 17, 2014
• Start date: October 2012

Study information

• Verified date: November 2014
• Source: Fab'entech
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthoritySingapore: Domain Specific Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the clinical and laboratory safety and to determine the pharmacokinetic profile of FBF001.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• subject between 21-40 years old

• with body mass index in the range 18 to 30 Kg/m2

Exclusion Criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness

• Any vaccination within three months before the inclusion

• Any vaccination against H5N1 virus

• Planned receipt of any vaccine during the study

• Any infectious disease within the month before the inclusion

• Any history of animal proteins allergy, animal allergy and/or any drug, food and pollen allergy

• Who has received blood or plasma derivatives (human or animal) in the three months preceding the initiation of the study

• Any medication within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avian Influenza

Intervention

Biological:
• FBF001

Drug:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fab'entech

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	mmHg	The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization	Yes
Primary	ECG evaluation	12-lead ECG	The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization	Yes
Primary	Haematology	Normal values of haematology parameters	The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization	Yes
Primary	Complement activation assay	ng/mL	Before dosing, at the end of infusion and 2hours after the beginning	Yes
Primary	Heart rate	bpm	The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization	Yes
Primary	Oral temperature	Celcius degree	The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization	Yes
Primary	Body weight	kg	The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization	Yes
Primary	Blood chemistry	Normal values of blood chemistry parameters	The subjects will be followed during their hospitalization stay (2 days or 6 days) and up to an average of 3 weeks after hospitalization	Yes