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NCT06109948 · ClinicalTrials.gov registry record · Early Phase 1

Study to Assess the Safety, Tolerability, PK and PD of ABX1100

A Early Phase 1 study of Healthy and Late Onset Pompe Disease, sponsored by Aro Biotherapeutics.

Active
Registry status
Early Phase 1
Development phase
46
Enrollment target
5
Study locations

NCT06109948 is a Early Phase 1 study of Healthy and Late Onset Pompe Disease that is active but no longer recruiting, run by Aro Biotherapeutics. The registered enrollment target is 46 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT06109948, a Early Phase 1 study of Healthy and Late Onset Pompe Disease, is active but no longer recruiting, sponsored by Aro Biotherapeutics.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
46 participants
Enrollment target
5
Study locations

Study Summary

Study ABX1100-1001 is a first-in-human (FIH), phase 1 study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) and multiple doses (MD) of ABX1100 administered intravenously to healthy participants and patients with LOPD. * Part A features a SAD study with a double-blind, placebo-controlled, randomized design in NHVs involving 3 cohorts (A1-A3). This Part also includes a single dose, open-labeled cohort (A4) in NHVs which will commence after cohorts A1-3. * Part B is a MD, double-blind, placebo-controlled, randomized design in NHVs. The MD Part B will commence after completion of Cohorts A1, A2 and A3 in the SAD Part A and SRC review of these 3 cohorts. * Part C opened for enrollment after the Safety Review Committee (SRC) review of safety, PK and PD data from both Part A and Part B. Part C is a MD, open-label design in patients with Late-Onset Pompe Disease.

Conditions Studied

Healthy Late Onset Pompe Disease

Interventions

  • DRUG ABX1100 injection for IV infusion
  • DRUG Placebo injection for IV infusion

Study Locations (5)

California

  • UCI - Orange

Missouri

  • Washington University School of Medicine - St Louis

Virginia

  • Lysosomal and Rare Disorders Research and Treatment Center, Inc - Fairfax

Alberta

  • MAGIC clinic - Calgary

Ontario

  • McMaster University - Hamilton

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2023-10-19
Est. Completion 2026-02
Phase Early Phase 1

Sponsor

Aro Biotherapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06109948

The ClinicalTrials.gov registry entry for NCT06109948 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The listed sponsor is Aro Biotherapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which ABX1100 injection for IV infusion is the first listed.

NCT06109948 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Missouri, Virginia.

Frequently Asked Questions

What is clinical trial NCT06109948 about?

NCT06109948 is a clinical study titled "Study to Assess the Safety, Tolerability, PK and PD of ABX1100". Study ABX1100-1001 is a first-in-human (FIH), phase 1 study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) and multiple doses (MD) of ABX1100 administered intravenously to healthy participants and patients with LOPD. * Part A features a SA...

What is the current status of trial NCT06109948?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 46 participants. The study started on 2023-10-19. Estimated completion is 2026-02.

What conditions does trial NCT06109948 study?

This clinical trial studies the following conditions: Healthy, Late Onset Pompe Disease.

What interventions are being tested in trial NCT06109948?

The interventions under investigation include: ABX1100 injection for IV infusion (DRUG), Placebo injection for IV infusion (DRUG).

Who is sponsoring clinical trial NCT06109948?

This trial is sponsored by Aro Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06109948 being conducted?

This trial has 5 study locations across California, Missouri, Virginia, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.