Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE July 21, 2020
First Posted Date  ICMJE July 24, 2020
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE September 8, 2020
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Number of subjects with adverse events [ Time Frame: Screening to end of study, up to 18 weeks ]
    Listing and summary of AE incidence
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Maximum observed plasma concentration, Cmax [ Time Frame: Predose to Day 91 (SAD) and Day 127 (MAD) ]
    Of ADX-914
  • Time to reach maximum observed plasma concentration, Tmax [ Time Frame: Predose to Day 91 (SAD) and Day 127 (MAD) ]
    Of ADX-914
  • Area Under the plasma concentration time curve, AUC [ Time Frame: Predose to Day 91 (SAD) and Day 127 (MAD) ]
    Of ADX-914
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
Official Title  ICMJE A Double-Blind, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of ADX-914 in Healthy Volunteers
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Safety Issues
Intervention  ICMJE
  • Drug: ADX-914
    Single dose from 0.1mg/kg to TBD
  • Drug: Placebo
    Matching single dose placebo
  • Drug: ADX-914
    Multiple dose from TBD to TBD
  • Drug: Placebo
    Matching multiple dose placebo
Study Arms  ICMJE
  • Experimental: Experimental: Cohort 1:1 - 1:6 ADX-914
    ADX-914 single SC dose
    Intervention: Drug: ADX-914
  • Placebo Comparator: Placebo Comparator: Cohort 1:1 - 1:6 placebo
    Placebo single SC dose
    Intervention: Drug: Placebo
  • Experimental: Experimental: Cohort 2:1- 2:3
    ADX-914 multiple SC dose once every 2 weeks for 6 weeks
    Intervention: Drug: ADX-914
  • Placebo Comparator: Placebo Comparator: Cohort 2:1- 2:3
    Placebo multiple SC dose once every 2 weeks for 6 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2020)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: PI 1800 243 733 recruitment@nucleusnetwork.com.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04485481
Other Study ID Numbers  ICMJE ADX-914-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Q32 Bio Inc.
Study Sponsor  ICMJE Q32 Bio Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Q32 Bio Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP