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Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04485481
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Q32 Bio Inc.

Brief Summary:
A two (2) part study to evaluate the safety, tolerability and PK of ADX-914

Condition or disease Intervention/treatment Phase
Safety Issues Drug: ADX-914 Drug: Placebo Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Double-Blind, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of ADX-914 in Healthy Volunteers
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
Experimental: Experimental: Cohort 1:1 - 1:6 ADX-914
ADX-914 single SC dose
Drug: ADX-914
Single dose from 0.1mg/kg to TBD

Placebo Comparator: Placebo Comparator: Cohort 1:1 - 1:6 placebo
Placebo single SC dose
Drug: Placebo
Matching single dose placebo

Experimental: Experimental: Cohort 2:1- 2:3
ADX-914 multiple SC dose once every 2 weeks for 6 weeks
Drug: ADX-914
Multiple dose from TBD to TBD

Placebo Comparator: Placebo Comparator: Cohort 2:1- 2:3
Placebo multiple SC dose once every 2 weeks for 6 weeks
Drug: Placebo
Matching multiple dose placebo




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: Screening to end of study, up to 18 weeks ]
    Listing and summary of AE incidence

  2. Number of subjects with Physical exam findings [ Time Frame: Screening to end of study, up to 18 weeks ]
    Listing of clinically significant changes in PE findings

  3. Number of subjects with Clinical safety lab changes [ Time Frame: Screening to end of study, up to 18 weeks ]
    Listing and change from baseline to end of study

  4. Number of subjects with Systolic blood pressure changes [ Time Frame: Screening to end of study, up to 18 weeks ]
    Listing and change from baseline to end of study

  5. Number of subjects with Heart rate changes [ Time Frame: Screening to end of study, up to 18 weeks ]
    Listing and change from baseline to end of study

  6. Number of subjects with 12 Lead ECG changes [ Time Frame: Screening to end of study, up to 18 weeks ]
    Change in 12-lead ECG parameters from baseline to end of study


Secondary Outcome Measures :
  1. Maximum observed plasma concentration, Cmax [ Time Frame: Predose to Day 91 (SAD) and Day 127 (MAD) ]
    Of ADX-914

  2. Time to reach maximum observed plasma concentration, Tmax [ Time Frame: Predose to Day 91 (SAD) and Day 127 (MAD) ]
    Of ADX-914

  3. Area Under the plasma concentration time curve, AUC [ Time Frame: Predose to Day 91 (SAD) and Day 127 (MAD) ]
    Of ADX-914



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485481


Contacts
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Contact: PI 1800 243 733 recruitment@nucleusnetwork.com.au

Locations
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Australia, Victoria
Nucleus Network Recruiting
Melbourne, Victoria, Australia, 3004
Contact: PI    61 3 9076 8960    j.lickliter@nucleusnetwork.com.au   
Sponsors and Collaborators
Q32 Bio Inc.
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Responsible Party: Q32 Bio Inc.
ClinicalTrials.gov Identifier: NCT04485481    
Other Study ID Numbers: ADX-914-001
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No