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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

NCT02429102

Healthy

COMPLETED PHASE1

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dose of TT-00920 in Healthy Subjects

NCT05043792

Healthy

COMPLETED PHASE1

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants

NCT06311760

Healthy Participants Study

COMPLETED PHASE1

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects

NCT02834442

Healthy

COMPLETED PHASE1

A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China

NCT03235778

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FB825

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

Group Type EXPERIMENTAL

FB825

Intervention Type DRUG

FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution containing no active ingredients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FB825

FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection

Intervention Type DRUG

Placebo

Solution containing no active ingredients

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes