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

PHASE1UNKNOWN

This is a multicenter, international, three-part, Phase 1 study designed to evaluate the safety, tolerability, and PK of rising single doses of AT-02 in healthy volunteers and in subjects with systemic amyloidosis and to assess the safety, tolerability, and PK of multiple doses of AT-02 in subjects with systemic amyloidosis.

Study details:

Systemic amyloidosis is an incurable disease, and about 20% of patients with cardiac or advanced kidney involvement experience early deaths (\<1 year). Despite recent progress in proteasome inhibitors, chemotherapies, and immunotherapies that target plasma cells have greatly improved the prognosis of patients with systemic amyloidosis, median survival remains low at approximately five years. AT-02 (INN: not yet available) is a full-length, humanized, recombinant immunoglobulin 1 (IgG1)-like glycoprotein monoclonal antibody (mAb) that is being developed to treat systemic amyloidosis.

This is a three-part, Phase 1 study designed to evaluate the safety, tolerability, and PK of rising single doses of AT-02 in healthy volunteers (HV) and in subjects with systemic amyloidosis (SA) and to assess the safety, tolerability, and PK of multiple doses of AT-02 in subjects with systemic amyloidosis. Part 1 is a double-blind, single-center, single-ascending dose escalation study in HV to assess the safety, tolerability, and PK of AT-02. Healthy volunteers between 18 to 56 years of will be enrolled in the Part 1 study.

Part 2 is an open-label, single-ascending dose escalation study in subjects with systemic amyloidosis to assess the safety, tolerability, and PK of AT-02 and to identify a maximum tolerated dose (MTD). Subjects with SA over 18 years of age will be involved in the Part 2 study. Part 3 is an open-label, multiple-ascending dose, dose escalation study in subjects with systemic amyloidosis to assess the safety, tolerability, PK, PD, and clinical activity of multiple doses of AT-02.

Subjects with SA ≥18 and ≤85 years of age will be involved in the Part 3 study.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Understands the study procedures and can give signed informed consent
  2. Male or female between >18 and <56 years of age.
  3. Willing and able to comply with this protocol and informed consent and be available for the entire duration of the study.
  4. Willing to abstain from alcohol and strenuous physical activity (i.e., strenuous or unaccustomed weightlifting, running, bicycling, etc.) from 48 hours prior to study treatment administration until discharge from the clinical unit and prior to each outpatient visit.
  5. In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at Screening and Phase 1 unit Check-in.
  6. Has body mass index (BMI) of 18 to 32 kg/m2, inclusive.
  7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
  8. Must not be breastfeeding, lactating, or planning a pregnancy during the study period.
  9. WOCBP who are not exclusively in same-sex relationships must agree to remain abstinent (complete avoidance of heterosexual intercourse) or use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, during the treatment period and for at least 105 days after the last dose of study intervention.
  10. Postmenopausal females under the age of 55 years must have a documented serum follicle stimulating hormone (FSH) level >40 mIU/mL to confirm menopause.
  11. WONCBP must agree to remain abstinent (complete avoidance of intercourse) or the male partners of WONCBP participants must wear a condom to protect against the transfer of study intervention through bodily fluids during the treatment period and for at least 105 days after the last dose of study intervention.
  12. Male participants must inform their female sexual partners who are WOCBP of the contraceptive requirements of the protocol and are expected to adhere to using contraception with their partner.
  13. Male participants with female sexual partners who are WOCBP must agree to remain abstinent (complete avoidance of heterosexual intercourse) or use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, during the treatment period and for at least 165 days after the last dose of study intervention.
  14. Male participants must not donate sperm for at least 165 days after the last dose of study intervention.
  15. Male participants with potentially postmenopausal partners who are under the age of 55 years must use condoms unless their partner's postmenopausal status has been confirmed by FSH level.
  16. Male participants in same-sex relationships or in relationships with WONCBP must agree to remain abstinent (complete avoidance of intercourse) or use a condom to prevent exposure of the partner to study intervention through ejaculate/seminal fluid during the treatment period and for at least 165 days after the last dose of study intervention.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT05521022

Intervention or treatment

DRUG: AT-02

OTHER: AT-02 (Placebo)

Conditions

  • Amyloidosis; Systemic

  • Condition: Amyloidosis; Systemic

  • DRUG: AT-02 and other drugs

  • Herston, Queensland, Australia and more

  • Sponsor: Attralus, Inc.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Q-Pharm Pty Ltd

Select from list below to view details:

  • Q-Pharm Pty Ltd

    Herston, Queensland, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia

  • Flinders Medical Centre

    Bedford Park, South Australia, Australia

  • Box Hill Hospital

    Box Hill, Victoria, Australia

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Who is running the clinical trial?

AI

Attralus, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part 1 AT-02
  • Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Drug: AT-02 Dosage: 30mg to 1000mg Dosage Form \& Route of Admin: Solution for IV Infusion
Drug: AT-02
    PLACEBO_COMPARATOR: Part 1 Placebo
    • Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Dosage Form \& Route of Admin: Normal Saline Solution for IV Infusion
    Other: AT-02 (Placebo)
      EXPERIMENTAL: Part 2 AT-02
      • 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
      Drug: AT-02
        EXPERIMENTAL: Part 3 AT-02
        • 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
        Drug: AT-02

          What is the study measuring?

          Primary Outcome

          MeasureDescriptionTime Frame
          Incidence and severity of treatment-emergent adverse events (TEAEs) from Day 1 to end of study (EOS).Safety will be assessed by review of clinical laboratory parameters and incidence and severity of TEAEs (graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5).Up to 57+/-7 days
          Incidence of dose-limiting toxicities (DLTs) in subjects with systemic amyloidosis.A DLT is defined as any related TEAE with a National Cancer Institute (NCI) CTCAE version 5.0 Grade ≥3 which also represents a shift from Baseline clinical status of \>1 NCI CTCAE Grade.Up to 85+/-7 Days
          Incidence and frequency of abnormal and clinically significant abnormal clinical laboratory parameter values.Not SpecifiedUp to 85+/-7 Days
          Incidence of treatment-emergent anti-drug antibodies (ADA)The number and percentage of subjects who develop detectable ADA will be summarized by dose cohort.Up to 85+/-7 Days

          Secondary Outcome

          MeasureDescriptionTime Frame
          To determine the plasma pharmacokinetics (PK) profile of AT-02Parameter: time to maximum observed AT-02 concentration (Tmax).Up to 85+/-7 Days
          To determine the plasma pharmacokinetics (PK) profile of AT-02Parameter: maximum observed concentration of AT-02 (Cmax).Up to 85+/-7 Days
          To determine the plasma pharmacokinetics (PK) profile of AT-02Parameter: area under the plasma concentration versus time curve (AUC).Up to 85+/-7 Days
          To determine the plasma pharmacokinetics (PK) profile of AT-02Parameter: volume of distribution at steady state (Vss).Up to 85+/-7 Days
          To determine the plasma pharmacokinetics (PK) profile of AT-02Parameter: total body clearance (CL) of AT-02.Up to 85+/-7 Days
          To determine the plasma pharmacokinetics (PK) profile of AT-02Parameter: AT-02 half-life (t1/2).Up to 85+/-7 Days
          Are you running this trial?If you're a clinic or sponsor, you can claim this study.
          Claim this trial

          References

          Clinical Trials Gov: Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis

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