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A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection

NCT05251090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-08-22

No results posted yet for this study

Summary

Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in Severe Hemophilia A.

Conditions

Interventions

DRUG

ADVATE

50 international units (IU)/kg, a single dose.

DRUG

FRSW107

50 IU/kg, a single dose.

Sponsors & Collaborators

  • Jiangsu Gensciences lnc.

    lead INDUSTRY

Principal Investigators

  • Runhui Wu, PhD · Beijing Children's Hospital

  • Xiaoling Wang, MA.Sc · Beijing Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2021-11-15
Completion
2022-05-09

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 NCT05251090 on ClinicalTrials.gov