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

NCT04485481 | Completed Phase 1

• 1 other identifier: ADX-914-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (6)

• Number of subjects with adverse events

  Listing and summary of AE incidence

  Screening to end of study, up to 18 weeks

• Number of subjects with Physical exam findings

  Listing of clinically significant changes in PE findings

  Screening to end of study, up to 18 weeks

• Number of subjects with Clinical safety lab changes

  Listing and change from baseline to end of study

  Screening to end of study, up to 18 weeks

• Number of subjects with Systolic blood pressure changes

  Listing and change from baseline to end of study

  Screening to end of study, up to 18 weeks

• Number of subjects with Heart rate changes

  Listing and change from baseline to end of study

  Screening to end of study, up to 18 weeks

• Number of subjects with 12 Lead ECG changes

  Change in 12-lead ECG parameters from baseline to end of study

  Screening to end of study, up to 18 weeks

Secondary Outcomes (3)

• Maximum observed plasma concentration, Cmax

  Predose to Day 91 (SAD) and Day 127 (MAD)

• Time to reach maximum observed plasma concentration, Tmax

  Predose to Day 91 (SAD) and Day 127 (MAD)

• Area Under the plasma concentration time curve, AUC

  Predose to Day 91 (SAD) and Day 127 (MAD)

Study Arms (4)

Experimental: Cohort 1:1 - 1:6 ADX-914

EXPERIMENTAL

ADX-914 single SC dose

Drug: ADX-914

Placebo Comparator: Cohort 1:1 - 1:6 placebo

PLACEBO COMPARATOR

Placebo single SC dose

Drug: Placebo

Experimental: Cohort 2:1- 2:3

EXPERIMENTAL

ADX-914 multiple SC dose once every 2 weeks for 6 weeks

Drug: ADX-914

Placebo Comparator: Cohort 2:1- 2:3

PLACEBO COMPARATOR

Placebo multiple SC dose once every 2 weeks for 6 weeks

Drug: Placebo

Interventions

ADX-914 DRUG

Single dose from 0.1mg/kg to TBD

Experimental: Cohort 1:1 - 1:6 ADX-914

Placebo DRUG

Matching single dose placebo

Placebo Comparator: Cohort 1:1 - 1:6 placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Q32 Bio Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: September 8, 2020
• Primary Completion: January 12, 2022
• Study Completion: January 12, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)