Status:
COMPLETED
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
Lead Sponsor:
Q32 Bio Inc.
Conditions:
Safety Issues
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
A two (2) part study to evaluate the safety, tolerability and PK of ADX-914
Detailed Description
Part 1 - SAD: 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 matchi...
Eligibility Criteria
Inclusion
- Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG recording
- Men and women age 18-50
Exclusion
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels greater than 1.5 x the upper limit of normal (ULN) at Screening or Day -1.
- 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.
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04485481
Start Date
September 8 2020
End Date
January 12 2022
Last Update
July 28 2022
Active Locations (1)
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1
Nucleus Network
Melbourne, Victoria, Australia, 3004