- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06109948
Study to Assess the Safety, Tolerability, PK and PD of ABX1100
May 8, 2024 updated by: Aro Biotherapeutics
A Phase 1, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABX1100 in Normal Healthy Volunteers
Study ABX1100-1001 is a first-in-human (FIH), phase 1 study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a single ascending dose (SAD) and multiple doses (MD) of ABX1100 administered intravenously to healthy participants.
- Part A features a SAD study with a double-blind, placebo-controlled, randomized design in NHVs involving 3 cohorts (A1-A3). This Part also includes a single dose, open-labeled cohort (A4) in NHVs which will commence after cohorts A1-3.
- Part B is a MD, double-blind, placebo-controlled, randomized design in NHVs. The MD Part B will commence after completion of Cohorts A1, A2 and A3 in the SAD Part A and SRC review of these 3 cohorts.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
38
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aro Study Information Center
- Phone Number: 215-544-1175
- Email: ABX1100@arobiotx.com
Study Locations
-
-
-
Toronto, Canada
- Recruiting
- Study Site
-
Contact:
- Study Coordinator
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive and weight between 50 and 90 kg, inclusive.
- Agree not to have a tattoo or body piercing until the end of the study.
- Agree not to receive COVID-19 vaccination from 7 days prior to first study drug administration until at least 7 days after the last study drug administration.
- Agree not to receive a vaccination (live attenuated vaccine) during the study and until 60 days after the study has ended (last study procedure).
- Willing to undergo needle muscle biopsies.
- Willing to avoid strenuous activities 48 hours before needle muscle biopsy and throughout the study.
- Female participants who are sexually active with a non-sterilized partner must be non-pregnant and non-lactating and agree to use a highly effective method of contraception.
- Males of childbearing potential must agree to use a highly effective method of contraception with female sexual partners of childbearing potential and not donate sperm during study participation and for 90 days after last administration of study drug ABX1100 or placebo.
Exclusion Criteria:
- Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition.
- History of any inherited or acquired skeletal muscle diseases (for example, Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD), Limb-Girdle Muscular Dystrophy (LGMD), Myotonic Dystrophy, Spinal Muscular Atrophy (SMA), Polymyositis, Rhabdomyolysis and Inclusion Body Myositis (IBM).
- History of any inherited or acquired cardiac disease including congestive heart failure, ischemic heart disease, or arrhythmias; an abnormal ECG.
- History of cancer within past 5 years, with the exception of treated or excised skin basal cell carcinoma.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the screening visit
- Presence of any significant physical or organ abnormality.
- Major surgery within 6 months prior to the start of the study.
- Current smoker, recent history of smoking and/or use of any nicotine-containing products (within past 6 months).
- A known history or positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody or human immunodeficiency virus (HIV) infection.
- Currently participating in another investigational trial or have received any investigational drug within the past 30 days.
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?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part B Multi-dose (active)
Subjects will receive 1 IV dose of ABX1100 on Day 1 and Day 29 each.
|
Centyrin protein-siRNA conjugate
|
Placebo Comparator: Part B Multi-dose (placebo)
Subjects will receive 1 IV dose of placebo on Day 1 and Day 29 each.
|
placebo saline injection
|
Experimental: Part A Cohort 1-4 Single Dose (active)
Subjects will receive 1 single IV dose of ABX1100 on Day 1.
|
Centyrin protein-siRNA conjugate
|
Placebo Comparator: Part A Cohort 1-3 Single Dose (placebo)
Subjects will receive 1 single IV dose of placebo on Day 1.
|
placebo saline injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame: up to 16 weeks
|
Adverse Events will be graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Adverse events (AEs) will be reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and echocardiograms from the time informed consent is signed through 8 weeks after ABX1100 administration for Part A and through 12 weeks after ABX1100 administration for Part B. AEs will be considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.
|
up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma pharmacokinetics as measured by Cmax
Time Frame: 0-24 hours after ABX1100 administration
|
Plasma samples will be taken pre-dose, 10 min, end of infusion, 0.5, 1, 3, 6, 9, 12 and 24 hours after the start of ABX1100 administration
|
0-24 hours after ABX1100 administration
|
Plasma pharmacokinetics as measured by Tmax
Time Frame: 0-24 hours after ABX1100 administration
|
Plasma samples will be taken pre-dose, 10 min, end of infusion, 0.5, 1, 3, 6, 9, 12 and 24 hours after the start of ABX1100 administration
|
0-24 hours after ABX1100 administration
|
Plasma pharmacokinetics as measured by AUC
Time Frame: 0-24 hours after ABX1100 administration
|
Plasma samples will be taken pre-dose, 10 min, end of infusion, 0.5, 1, 3, 6, 9, 12 and 24 hours after the start of ABX1100 administration
|
0-24 hours after ABX1100 administration
|
Immunogenicity of AXB1100 as measured by anti-ABX1100 antibodies in serum
Time Frame: Up to 8 weeks
|
Plasma samples will be taken pre-dose, Day 15 and Day 29 after ABX1100 administration (Part A); Plasma samples will be taken pre-dose, Day 15, Day 29 Day 43 and Day 57 after ABX1100 administration (Part B)
|
Up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2023
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
October 19, 2023
First Submitted That Met QC Criteria
October 25, 2023
First Posted (Actual)
October 31, 2023
Study Record Updates
Last Update Posted (Estimated)
May 10, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ABX1100-1001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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