A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Ascending Intravenous Doses of FB825
Overview
- Phase
- Phase 1
- Intervention
- FB825
- Conditions
- Healthy
- Sponsor
- Fountain Biopharma Inc.
- Enrollment
- 54
- Primary Endpoint
- Number of Participants with Adverse events (AE)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825
Investigators
Eligibility Criteria
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 -
- •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.
Arms & Interventions
FB825
6 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg
Intervention: FB825
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Adverse events (AE)
Time Frame: Up to day140
Clinical laboratory test results (hematology, coagulation, serum chemistry[including liver function tests], and urinalysis)
Time Frame: Up to day140
Vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and oral body temperature)
Time Frame: Up to day140
12-lead ECG results
Time Frame: Up to day140
Physical examination findings
Time Frame: Up to day140
Secondary Outcomes
- 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)