Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
NCT ID: NCT04485481
Last Updated: 2022-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2020-09-08
2022-01-12
Brief Summary
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Detailed Description
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It is expected that there will be up to 6 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo.
It is planned that for each cohort in Part 1 a staggered 'sentinel' dose design will be used.
Part 2 - MAD It is expected that there will be up to 3 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo. Doses will occur every 2 weeks, for a total of 4 doses.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Experimental: Cohort 1:1 - 1:6 ADX-914
ADX-914 single SC dose
ADX-914
Single dose from 0.1mg/kg to TBD
Placebo Comparator: Cohort 1:1 - 1:6 placebo
Placebo single SC dose
Placebo
Matching single dose placebo
Experimental: Cohort 2:1- 2:3
ADX-914 multiple SC dose once every 2 weeks for 6 weeks
ADX-914
Multiple dose from TBD to TBD
Placebo Comparator: Cohort 2:1- 2:3
Placebo multiple SC dose once every 2 weeks for 6 weeks
Placebo
Matching multiple dose placebo
Interventions
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ADX-914
Single dose from 0.1mg/kg to TBD
Placebo
Matching single dose placebo
ADX-914
Multiple dose from TBD to TBD
Placebo
Matching multiple dose placebo
Eligibility Criteria
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Inclusion Criteria
* Men and women age 18-50
Exclusion Criteria
* QT-interval measurements corrected according to the Fridericia rule (QTcF \>450 msec) during controlled rest at Screening or family history of long QT syndrome.
* Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the Investigator, may interfere with the interpretation of QTc-interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
* A clinically significant vital signs abnormality, as judged by the Investigator, at Screening, or Day -1. This includes, but is not limited to, the following, in the supine position: (a) systolic blood pressure \<90 or \>140 mmHg, (b) diastolic blood pressure \<40 or \>90 mmHg, or (c) heart rate \<40 or \>100 beats per minute.
18 Years
50 Years
ALL
Yes
Sponsors
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Q32 Bio Inc.
INDUSTRY
Responsible Party
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Locations
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Nucleus Network
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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ADX-914-001
Identifier Type: -
Identifier Source: org_study_id
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