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A Trial of the Safety and Efficacy of Single-Dose Administration of ANB-010 in Subjects With Hemophilia A

NCT06185335 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-24

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-010 in subjects with hemophilia A. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.

Conditions

Interventions

GENETIC

ANB-010, dose 1

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

GENETIC

ANB-010, dose 2

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

GENETIC

ANB-010, dose 3

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

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Arina V Zinkina-Orikhan, PhD · 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
2023-07-26
Primary Completion
2025-12-31
Completion
2033-06-30

Countries

  • Russia

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 NCT06185335 on ClinicalTrials.gov