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Monoclonal Antibodies

ABX1100 Safety and Tolerability for Healthy Subjects

Phase < 1
Recruiting
Research Sponsored by Aro Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive and weight between 50 and 90 kg, inclusive.
Willing to undergo needle muscle biopsies.
Must not have
History of any inherited or acquired skeletal muscle diseases (for example, Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD), Limb-Girdle Muscular Dystrophy (LGMD), Myotonic Dystrophy, Spinal Muscular Atrophy (SMA), Polymyositis, Rhabdomyolysis and Inclusion Body Myositis (IBM).
History of any inherited or acquired cardiac disease including congestive heart failure, ischemic heart disease, or arrhythmias; an abnormal ECG.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours after abx1100 administration

Summary

This trial is testing a new drug in healthy volunteers, to see if it is safe, how it works in the body, and effects of multiple doses.

Who is the study for?
Healthy adults with a BMI of 18.0-32.0 and weight between 50-90 kg can join this trial. They must not get tattoos, piercings, or certain vaccinations during the study period and avoid strenuous activities before muscle biopsies. Women must use contraception if applicable, and men agree to do so with partners.
What is being tested?
The trial is testing ABX1100, a new drug given through IV infusion compared to a placebo (a substance with no active drug). It's done in two parts: one where subjects receive a single dose and another where they receive multiple doses to evaluate safety and effects on the body.
What are the potential side effects?
Since ABX1100 is being tested for the first time in humans, potential side effects are unknown but may include typical reactions related to IV infusions such as pain at injection site, allergic reactions or general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 18 and 32, and my weight is between 50kg and 90kg.
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I am willing to have muscle biopsies taken with a needle.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of inherited or acquired muscle diseases.
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I have no history of heart disease or abnormal heart tests.
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I do not have any major organ or physical abnormalities.
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I have smoked or used nicotine products in the last 6 months.
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I have not had major surgery in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours after abx1100 administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours after abx1100 administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of subjects with treatment-emergent adverse events (TEAEs)
Secondary study objectives
Immunogenicity of AXB1100 as measured by anti-ABX1100 antibodies in serum
Plasma pharmacokinetics as measured by AUC
Plasma pharmacokinetics as measured by Cmax
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part CExperimental Treatment1 Intervention
Late onset Pompe Disease patients will receive 1 dose of ABX1100 at Day 1 and Day 29 respectively.
Group II: Part B Multi-dose (active)Experimental Treatment1 Intervention
Subjects will receive 1 IV dose of ABX1100 on Day 1 and Day 29 each.
Group III: Part A Cohort 1-4 Single Dose (active)Experimental Treatment1 Intervention
Subjects will receive 1 single IV dose of ABX1100 on Day 1.
Group IV: Part A Cohort 1-3 Single Dose (placebo)Placebo Group1 Intervention
Subjects will receive 1 single IV dose of placebo on Day 1.
Group V: Part B Multi-dose (placebo)Placebo Group1 Intervention
Subjects will receive 1 IV dose of placebo on Day 1 and Day 29 each.

Find a Location

Who is running the clinical trial?

Aro BiotherapeuticsLead Sponsor
~22 spots leftby Dec 2025
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