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A Phase I of SS109 in Hemophilia A or and B With Inhibitors

NCT05651061 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-08-22

No results posted yet for this study

Summary

This phase I study aims to evaluate the safety, PK/PD and immunogenicity of SS109 in hemophilia A or and B with inhibitors. Twenty -seven patients are enrolled in study, and divided into five dose cohorts, from 30μg/kg to 360μg/kg. Dose 1 cohort enrolls three patients, each other dose cohorts enroll six patients. All patients included in the study will continue to be followed up until 28 days after SS109 administration.

Conditions

  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor
  • Factor VII Deficiency

Interventions

BIOLOGICAL

SS109

27 patients are enrolled in cohorts ,and will continue to be followed up until 28 days after SS109 administration for evaluating safety, PK/PD and immunogenicity.

Sponsors & Collaborators

  • Jiangsu Gensciences lnc.

    lead INDUSTRY

Principal Investigators

  • Renchi Yang · Hematology Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2023-03-31
Completion
2023-08-15

Countries

  • China

Study Locations

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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 NCT05651061 on ClinicalTrials.gov