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A Bridging Study of FB2001 in Healthy Subjects

NCT05197179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-06

No results posted yet for this study

Summary

In the first human clinical trial conducted in the United States, single and multiple dosing of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated the safety and PK of FB2001 in healthy Chinese population. This is a randomized, double-blind, placebo-controlled study of single and multiple dosing.

Conditions

Interventions

DRUG

FB2001

Subjects will be administered with FB2001 by intravenous (IV) infusion

OTHER

FB2001 placebo

Subjects will be administered with FB2001 by intravenous (IV) infusion

Sponsors & Collaborators

  • Frontier Biotechnologies Inc.

    lead INDUSTRY

Principal Investigators

  • Yun Liu · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-29
Primary Completion
2022-04-27
Completion
2022-06-02

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05197179 on ClinicalTrials.gov