Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825
Interventions
DRUGFB825
FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection
DRUGPlacebo
Solution containing no active ingredients
Sponsors
Fountain Biopharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject is male or female between 18 and 55 years of age, inclusive. 2. All female subjects must have a negative serum pregnancy test at screening and on Day -1. 3. The subject has a body weight ≥50 kg at screening and a body mass index of 18 to 30 kg/m2, inclusive. 4. The subject has a good health condition based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG. 5. The subject has a negative urine drug screen for alcohol, cotinine.
Exclusion criteria
1. Female subjects who are pregnant or lactating. 2. The subject has a past history of heart arrhythmias. 3. The subject has history of clinically significant diseases. 4. The subject has any history of a previous anaphylactic reaction. 5. Use of prescribed medication within 6 months of Day -1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical examination findings | 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 |
| Number of Participants with Adverse events (AE) | Up to day140 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total IgE serum concentrations | pre-dose, 5, 14, 29, 85, and 140 day post-dose | Blood will be collected to measure serum IgE concentrations. |
| Immunogenicity (Anti-FB825 antibody in serum) | pre-dose, 5, 14, 29, 85, and 140 day post-dose | Blood will be collected to measure Immunogenicity. |
| Composite of PK parameters | 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. |
Outcome results
None listed