← Back to Search

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours after abx1100 administration
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My BMI is between 18 and 32, and my weight is between 50kg and 90kg.
Select...
I am willing to have muscle biopsies taken with a needle.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with treatment-emergent adverse events (TEAEs)
Secondary outcome measures
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

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B Multi-dose (active)Experimental Treatment1 Intervention
Subjects will receive 1 IV dose of ABX1100 on Day 1 and Day 29 each.
Group II: Part A Single Dose (active)Experimental Treatment1 Intervention
Subjects will receive 1 single IV dose of ABX1100 on Day 1.
Group III: Part B Multi-dose (placebo)Placebo Group1 Intervention
Subjects will receive 1 IV dose of placebo on Day 1 and Day 29 each.
Group IV: Part A Single Dose (placebo)Placebo Group1 Intervention
Subjects will receive 1 single IV dose of placebo on Day 1.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Aro BiotherapeuticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the target demographic of this research limited to individuals 40 years or younger?

"As outlined in the requirements, only applicants aged 18-50 may be considered for inclusion."

Answered by AI

Does this medical investigation offer enrolment opportunities for eligible participants?

"In order to meet the requirements of this study, potential participants must be in good health and between 18-50 years old. 36 individuals are being recruited altogether."

Answered by AI

What are the known risks associated with Part A Single Dose (active)?

"As this is a phase 1 trial, with minimal data backing its safety and efficacy, Part A Single Dose (active) was assigned a score of 1 on our risk assessment scale."

Answered by AI

Does this research currently have openings for participants?

"This medical trial, which has been posted since October 19th 2023 is still actively recruiting participants as of the most recent update on October 25th."

Answered by AI

What is the size of the cohort involved in this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is presently enrolling, with the first post being published on October 19th of 2023 and a recent update occurring on October 25th of the same year. There are 36 individuals required to participate in trials at only 1 medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Safety, Tolerability, PK and PD of ABX1100
2023. "Study to Assess the Safety, Tolerability, PK and PD of ABX1100". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06109948.
~12 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top