AT-02 for Amyloidosis (AT02-001 Trial)

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

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Incidence of treatment-emergent anti-drug antibodies (ADA)

Secondary study objectives

2,2'-Dipyridyl

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