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Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)

NCT06120582 ยท Status: RECRUITING ยท Phase: PHASE1/PHASE2 ยท Type: INTERVENTIONAL ยท Enrollment: 28

Last updated 2025-06-13

No results posted yet for this study

Summary

The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-002 in subjects with hemophilia ะ’. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.

Conditions

  • Hemophilia B

Interventions

GENETIC

ANB-002, dose 1

Adeno-associated viral vector carrying the FIX gene single infusion at dose 1.

GENETIC

ANB-002, dose 2

Adeno-associated viral vector carrying the FIX gene single infusion at dose 2.

GENETIC

ANB-002, dose 3

Adeno-associated viral vector carrying the FIX gene single infusion at dose 3.

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Arina V Zinkina-Orikhan, MD ยท Director of Clinical Development Department, BIOCAD

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2025-11-30
Completion
2029-11-30

Countries

  • Belarus
  • Russia

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 NCT06120582 on ClinicalTrials.gov