Status:
COMPLETED
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB825 in Healthy Volunteers
Lead Sponsor:
Fountain Biopharma Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02309762
Start Date
March 1 2015
End Date
February 1 2016
Last Update
February 4 2016
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