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Part 3 AT-02 for Amyloidosis (AT02-001 Trial)

Q: Are there any available openings for patients to participate in this study?

Indeed, according to the information provided on clinicaltrials.gov, this study is currently seeking eligible participants. The initial posting of the study occurred on September 1st, 2022 and it was last updated on January 16th, 2024. A total of 100 individuals will be recruited from a pool of eleven different sites.

Q: What is the upper limit of participants involved in this clinical study?

Indeed, the information available on clinicaltrials.gov indicates that this clinical trial is currently seeking eligible participants. The initial posting of the study took place on September 1st, 2022 and it was last updated on January 16th, 2024. Across a total of eleven sites, one hundred individuals will be enrolled in this trial.

Q: Has Part 2 of the AT-02 trial received official approval from the FDA?

Based on the Phase 1 nature of this trial, our team at Power rates the safety of Part 2 AT-02 as a 1. This indicates that there is limited available data supporting both safety and efficacy.

Q: At how many different sites is this study currently being conducted?

Currently, this clinical trial is actively enrolling patients from a total of 11 sites. These sites are spread across various locations such as Overland Park, Cleveland, and Portland among others. To minimize travel requirements for participants who decide to enroll, it would be beneficial to select the site that is closest to their location.

Phase 1

Recruiting

Research Sponsored by Attralus, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female between >18 and <56 years of age.

Women of childbearing potential (WOCBP)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 85+/-7 days

Awards & highlights

AT02-001 Trial Summary

This trial is a study that will be conducted at multiple centers across the world. It will be done in three parts and is a Phase 1 study, which means it is the first step in testing

Who is the study for?

This trial is for healthy adults and those with systemic amyloidosis, aged between 18 and 56. Participants must understand the study, not consume alcohol or engage in strenuous activity before visits, have a BMI of 18-32 kg/m2, and women must not be pregnant or planning pregnancy. Contraception is required for sexually active participants.Check my eligibility

What is being tested?

The study tests AT-02's safety, tolerability, and pharmacokinetics (PK) - how the drug moves through the body. It involves rising single doses in healthy volunteers and multiple doses in systemic amyloidosis patients across international centers.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at injection sites, gastrointestinal issues like nausea or diarrhea, fatigue, allergic reactions or changes in blood work indicative of organ function.

AT02-001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19 and 55 years old.

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I am a woman who can become pregnant.

AT02-001 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 85+/-7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 85+/-7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 85+/-7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and frequency of abnormal and clinically significant abnormal clinical laboratory parameter values.

Incidence and severity of treatment-emergent adverse events (TEAEs) from Day 1 to end of study (EOS).

Incidence of dose-limiting toxicities (DLTs) in subjects with systemic amyloidosis.

+1 more

Secondary outcome measures

2,2'-Dipyridyl

AT02-001 Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 3 AT-02Experimental Treatment1 Intervention

Part 3 enrolling Systemic Amyloidosis Participants (Single-Arm, Open-label) Drug: AT-02 Dosage: Dose levels will be determined by the SRC. The starting dose in Part 3 will be determined by the SRC based on all available safety, tolerability, PK, and PD data from all prior cohorts Frequency: Multiple Doses Dosage Form & Route of Admin: Solution for IV Infusion

Group II: Part 2 AT-02Experimental Treatment1 Intervention

Part 2 enrolling Systemic Amyloidosis Participants (Single-Arm, Open-label) Drug: AT-02 Dosage: 300mg to 4000mg Frequency: Single Dose Dosage Form & Route of Admin: Solution for IV Infusion

Group III: Part 1 AT-02Experimental Treatment1 Intervention

Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Drug: AT-02 Dosage: 30mg to 1000mg Dosage Form & Route of Admin: Solution for IV Infusion

Group IV: Part 1 PlaceboPlacebo Group1 Intervention

Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Dosage Form & Route of Admin: Normal Saline Solution for IV Infusion

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novotech (Australia) Pty LimitedIndustry Sponsor

68 Previous Clinical Trials

7,322 Total Patients Enrolled

1 Trials studying Amyloidosis

120 Patients Enrolled for Amyloidosis

Attralus, Inc.Lead Sponsor

6 Previous Clinical Trials

250 Total Patients Enrolled

6 Trials studying Amyloidosis

250 Patients Enrolled for Amyloidosis

Frequently Asked Questions

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

Are there any available openings for patients to participate in this study?

"Indeed, according to the information provided on clinicaltrials.gov, this study is currently seeking eligible participants. The initial posting of the study occurred on September 1st, 2022 and it was last updated on January 16th, 2024. A total of 100 individuals will be recruited from a pool of eleven different sites."

Answered by AI

What is the upper limit of participants involved in this clinical study?

"Indeed, the information available on clinicaltrials.gov indicates that this clinical trial is currently seeking eligible participants. The initial posting of the study took place on September 1st, 2022 and it was last updated on January 16th, 2024. Across a total of eleven sites, one hundred individuals will be enrolled in this trial."

Answered by AI

Has Part 2 of the AT-02 trial received official approval from the FDA?

"Based on the Phase 1 nature of this trial, our team at Power rates the safety of Part 2 AT-02 as a 1. This indicates that there is limited available data supporting both safety and efficacy."

Answered by AI

At how many different sites is this study currently being conducted?

"Currently, this clinical trial is actively enrolling patients from a total of 11 sites. These sites are spread across various locations such as Overland Park, Cleveland, and Portland among others. To minimize travel requirements for participants who decide to enroll, it would be beneficial to select the site that is closest to their location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis

2022. "Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05521022.

All > Amyloidosis