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

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Amyloidosis; Systemic

In brief

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.

Key facts

Study ID

NCT05521022

Run by

Attralus, Inc.

People needed

100

Starts

2022-09-01

Expected to finish

2025-03-01

Last updated by the study team

2024-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligibility Criteria for Healthy Volunteers:
• Healthy volunteers are eligible to be included in the study only if all the following criteria apply:
• Understands the study procedures and can give signed informed consent
• Male or female between >18 and <56 years of age.
• Willing and able to comply with this protocol and informed consent and be available for the entire duration of the study.
• 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.
• 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.
• Has body mass index (BMI) of 18 to 32 kg/m2, inclusive.
• Women of childbearing potential (WOCBP)
• WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
• Must not be breastfeeding, lactating, or planning a pregnancy during the study period.
• 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.
• Postmenopausal females:
• a) Postmenopausal females under the age of 55 years must have a documented serum follicle stimulating hormone (FSH) level >40 mIU/mL to confirm menopause
• Women of non-childbearing potential (WONCBP) and female participants with vasectomized male partners:
• a) 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.
• Male participants:
• 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.
• 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.
• Male participants must not donate sperm for at least 165 days after the last dose of study intervention.
• 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.
• 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 Criteria for Part 2 Subjects with Systemic Amyloidosis
• Subjects with systemic amyloidosis are eligible to be included in the study only if all the following criteria apply:
• Understands the study procedures and can give signed informed consent

Where it is running

• Midwest Heart and Vascular — Overland Park, Kansas, United States (enrolling)
• Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• OHSU (Oregon Health & Science University) — Portland, Oregon, United States (enrolling)
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (enrolling)
• Q-Pharm Pty Ltd — Herston, Queensland, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (enrolling)
• Box Hill Hospital — Box Hill, Victoria, Australia (enrolling)
• Royal Perth Hospital — Perth, Western Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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