MedTrace Logo

The Safety and Tolerability Study With ER2001 Intravenous Injection Repetitive Treatment in Adults With Early Manifest Huntington's Disease.

NCT07344519 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-22

No results posted yet for this study

Summary

This is an open label, dose escalation clinic trial to evaluate safety, tolerability and pharmacokinetics with ER2001 Intravenous Injection repetitive treatment in Huntington's Disease patients who Completed Study ER2001-001（NCT06024265）. Furthermore, pharmacodynamics in particular target engagement, and clinical signs of efficacy will be assessed. This study will evaluate increasing doses of ER2001 in sequential cohorts. ER2001 was escalated over 3 dose levels . The planned duration of this additional treatment is 6 weeks for one course.

Conditions

  • Huntington Disease

Interventions

DRUG

ER2001 injection

The minimum initial dose is 0.08mg/kg, then escalate to 0.16mg/kg, and 0.32mg/kg. The planned duration of the treatment is 6 weeks, and ER2001 will be administrated intravenously at the first day of weeks 1, 2, 3, 4, 5, and 6.

Sponsors & Collaborators

  • ExoRNA Bioscience

    lead INDUSTRY

Principal Investigators

  • pingyi xu, Ph.D · First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2025-06-01
Completion
2026-01-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07344519 on ClinicalTrials.gov