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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: FB825
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FB825<br>6 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg | Drug: FB825<br>* FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Solution containing no active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse events (AE) |  | 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 | 
| Physical examination findings |  | Up to day140 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of PK parameters | 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. | Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose | 
| Total IgE serum concentrations | Blood will be collected to measure serum IgE concentrations. | pre-dose, 5, 14, 29, 85, and 140 day post-dose | 
| Immunogenicity (Anti-FB825 antibody in serum) | Blood will be collected to measure Immunogenicity. | pre-dose, 5, 14, 29, 85, and 140 day post-dose |