Amyloidosis; SystemicPhase 1AT02-001NCT05521022
Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis
A Phase 1 study testing AT-02 in people with Amyloidosis; Systemic, run by Attralus, Inc. at 11 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyloidosis; Systemic
- What is being tested?
- AT-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Sep 2022to 1 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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:
- 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
- Male or female ≥18 and ≤80 years of age.
- Mini Mental Status Exam (MMSE) score >27 (subjects >55 years of age only).
- Has a confirmed diagnosis of AL, ATTR, or other form of systemic amyloidosis, based on any one of the following:
- A histologic confirmation with a biopsy containing deposits of apple-green birefringent, Congophilic material or other amyloid staining (i.e., thioflavin T or sulfated alcian blue) with confirmatory immunohistochemistry, mass spectrometry or identification of an amyloidogenic genetic variant;
- Genetic screening with presence of amyloid-related pathology; or
- Amyloid-specific imaging study (e.g., bone scintigraphy and echocardiogram/CMR consistent with ATTR cardiac amyloid).
- Subjects with AL systemic amyloidosis must have achieved a hematologic very good partial response (VGPR) or complete response (CR) based on their most recent assessment (e.g., difference in free light chains <40 mg/L) and within 12 months of Screening and may be receiving maintenance daratumumab.
- Subjects with ATTR systemic amyloidosis may be receiving a TTR silencer (e.g., inotersen, vutrisiran, or patisiran) or a stabilizer (e.g., tafamadis or diflunisal), but not both.
- Women of childbearing potential (WOCBP):
- WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
- 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.
- Women of non-childbearing potential (WONCBP), and female participants with vasectomized male partners:
- 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.
- Postmenopausal females must have a documented serum FSH level >40 mIU/mL at Screening to confirm menopause.
- 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 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 3 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.
- Male or female ≥18 and ≤85 years of age.
- Has a confirmed diagnosis of ATTR cardiomyopathy (ATTR-CM), AL, or other form of systemic amyloidosis
- Imaging evidence of organ amyloid deposits.
- For ATTR cardiomyopathy subjects, genetic testing confirming wild type ATTR or identification of an amyloidogenic genetic variant is required. If genetic testing has not been performed prior to screening, then the test may be ordered during screening
- Subjects with ATTR cardiomyopathy may be receiving a TTR silencer (e.g., inotersen, vutrisiran, or patisiran) or a stabilizer (e.g., tafamadis or diflunisal), but not both.
- Subjects with AL systemic amyloidosis may be receiving maintenance daratumumab and must have
- Achieved a hematologic very good partial response (VGPR) or complete response (CR) based on their most recent assessment (e.g., difference in free light chains <40 mg/L) within 12 months of Screening or
- Achieved a partial hematologic response, is in stable condition (defined as >6 months without clonal or amyloidotic organ progression), is not receiving plasma cell directed (PCD) therapy and is not expected to require PCD therapy for the duration of the study.
- Women of childbearing potential (WOCBP):
- WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
- 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.
- Women of non-childbearing potential (WONCBP), and female participants with vasectomized male partners:
- 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.
- Postmenopausal females must have a documented serum FSH level >40 mIU/mL at Screening to confirm menopause.
- 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 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.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21287
Joban Vaishnav, Dr, jvaishn1@jhmi.edu
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Mazen Hanna, Dr, hannam@ccf.org
- Recruiting
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Carmen Cook, RN, 816-932-3410, carcook1@saint-lukes.org
- Recruiting
Midwest Heart and Vascular
Overland Park, Kansas, 66211
Vasvi Singh, Dr, Vasvi.singh@hcahealthcare.com
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Brian Drachman, Dr, drachman@pennmedicine.upenn.edu
- Recruiting
OHSU (Oregon Health & Science University)
Portland, Oregon, 97239
Ahmad Masri, Dr, masria@ohsu.edu
Australia5 sites, 5 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Joseph Selvanayagam
- Recruiting
Box Hill Hospital
Box Hill, Victoria, 3128
Simon Gibbs
- Recruiting
Q-Pharm Pty Ltd
Herston, Queensland, 4006
Richard Friend
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Graham Hillis
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Dariusz Korczyk, Dr
About this study
Official title: A Three-part, Phase 1, Single-ascending, and Multiple-ascending Dose Escalation Study in Healthy Volunteers and Subjects With Systemic Amyloidosis to Assess the Safety, Tolerability, and Pharmacokinetics of AT-02
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.
Read the detailed description
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.
- Conditions
- Amyloidosis; Systemic
- Being tested
- AT-02, AT-02 (Placebo)
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-02Drug
AT-02 via IV infusion
AT-02 (Placebo)Other
Normal saline solution via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 AT-02 | Experimental | Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Drug: AT-02 Dosage: 30mg to 1000mg Dosage Form \& Route of Admin: Solution for IV Infusion Receives: Drug: AT-02 |
| Part 1 Placebo | Placebo comparator | Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Dosage Form \& Route of Admin: Normal Saline Solution for IV Infusion Receives: Other: AT-02 (Placebo) |
| Part 2 AT-02 | Experimental | 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 Receives: Drug: AT-02 |
| Part 3 AT-02 | Experimental | 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 Receives: Drug: AT-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 85+/-7 Days
Incidence and frequency of abnormal and clinically significant abnormal clinical laboratory parameter values.
Measured: Up 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.
Measured: Up to 85+/-7 Days
Secondary outcomes (6)
To determine the plasma pharmacokinetics (PK) profile of AT-02
Parameter: time to maximum observed AT-02 concentration (Tmax).
Measured: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Parameter: maximum observed concentration of AT-02 (Cmax).
Measured: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Parameter: area under the plasma concentration versus time curve (AUC).
Measured: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Parameter: volume of distribution at steady state (Vss).
Measured: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Parameter: total body clearance (CL) of AT-02.
Measured: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Parameter: AT-02 half-life (t1/2).
Measured: Up to 85+/-7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis; SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attralus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521022
- Sponsor's protocol ID
- AT02-001
- Acronym
- AT02-001
- Status last verified
- Apr 2024
- First submitted
- 23 Aug 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-part, Phase 1, Single-ascending, and Multiple-ascending Dose Escalation Study in Healthy Volunteers and Subjects With Systemic Amyloidosis to Assess the Safety, Tolerability, and Pharmacokinetics of AT-02
- ClinicalTrials.gov ID
- NCT05521022
- Acronym / sponsor ID
- AT02-001 / AT02-001
- Conditions
- Amyloidosis; Systemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Attralus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 AT-02 | Experimental | Drug: AT-02Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Drug: AT-02 Dosage: 30mg to 1000mg Dosage Form \& Route of Admin: Solution for IV Infusion |
| Part 1 Placebo | Placebo comparator | Other: AT-02 (Placebo)Part 1 enrolling Healthy Volunteers (Randomised, Double-blind) Dosage Form \& Route of Admin: Normal Saline Solution for IV Infusion |
| Part 2 AT-02 | Experimental | Drug: AT-02Part 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 |
| Part 3 AT-02 | Experimental | Drug: AT-02Part 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (68 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-02AT-02 via IV infusion | Drug | Part 1 AT-02, Part 2 AT-02, Part 3 AT-02 |
| AT-02 (Placebo)Normal saline solution via IV infusion | Other | Part 1 Placebo |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) from Day 1 to end of study (EOS).
Time frame: Up to 57+/-7 days
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).
Incidence of dose-limiting toxicities (DLTs) in subjects with systemic amyloidosis.
Time frame: Up to 85+/-7 Days
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.
Incidence and frequency of abnormal and clinically significant abnormal clinical laboratory parameter values.
Time frame: Up to 85+/-7 Days
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: Up to 85+/-7 Days
The number and percentage of subjects who develop detectable ADA will be summarized by dose cohort.
6 secondary outcomes
To determine the plasma pharmacokinetics (PK) profile of AT-02
Time frame: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Time frame: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Time frame: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Time frame: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Time frame: Up to 85+/-7 Days
To determine the plasma pharmacokinetics (PK) profile of AT-02
Time frame: Up to 85+/-7 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AT-02 in people with Amyloidosis; Systemic, run by Attralus, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 68 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Stephens, RN (3212287400, Sstephens@attralus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) from Day 1 to end of study (EOS). (time frame: Up to 57+/-7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.