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

Fountain Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: FB825

Study type: Interventional

Funder types: Industry

Identifiers

NCT02309762

FB825CLCT01

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

54 participants in 2 patient groups, including a placebo group

FB825

Experimental group

Description:

6 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg

Treatment:

Drug: FB825

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo