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3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)

NCT05039268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-10-11

Study results available
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Summary

Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis (ALS).

Conditions

Interventions

DRUG

3K3A-APC Protein

3K3A-APC with intravenous dosing of five doses of either 15mg or 30mg at 12 hourly interval. The first 8 patients will receive 15mg dose, and the next 8 patients will receive 30mg dose.

Sponsors & Collaborators

  • ZZ Biotech, LLC

    collaborator INDUSTRY

  • Macquarie University, Australia

    lead OTHER

Principal Investigators

  • Dominic Rowe, PhD, MD · Macquarie University, Australia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2022-09-12
Completion
2022-09-12
FDA Drug
Yes

Countries

  • Australia

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 NCT05039268 on ClinicalTrials.gov