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Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001

NCT06119659 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-11-07

No results posted yet for this study

Summary

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels.

Conditions

  • Hemophilia B Without Inhibitor

Interventions

DRUG

Low dose KL001

Subjects will be dosed with single dose of KL001 at 2.5x10\^12 vg/kg.

DRUG

Middle dose KL001

Subjects will be dosed with single dose of KL001 at 5.0x10\^12 vg/kg.

DRUG

High dose KL001

Subjects will be dosed with single dose of KL001 at 1.0x10\^13 vg/kg.

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Principal Investigators

  • He Huang, PhD&MD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-20
Primary Completion
2024-06-30
Completion
2025-07-10

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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 NCT06119659 on ClinicalTrials.gov