Safety IssuesPhase 1NCT04485481
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
A Phase 1 study testing ADX-914 in people with Safety Issues, run by Q32 Bio Inc. at 1 site in Australia.
Trial summary
A two (2) part study to evaluate the safety, tolerability and PK of ADX-914 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- ADX-914
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Sep 2020to 12 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A two (2) part study to evaluate the safety, tolerability and PK of ADX-914
Read the 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.
- Conditions
- Safety Issues
- Being tested
- ADX-914, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-914Drug
Single dose from 0.1mg/kg to TBD
PlaceboDrug
Matching single dose placebo
ADX-914Drug
Multiple dose from TBD to TBD
PlaceboDrug
Matching multiple dose placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cohort 1:1 - 1:6 ADX-914 | Experimental | ADX-914 single SC dose Receives: Drug: ADX-914 |
| Placebo Comparator: Cohort 1:1 - 1:6 placebo | Placebo comparator | Placebo single SC dose Receives: Drug: Placebo |
| Experimental: Cohort 2:1- 2:3 | Experimental | ADX-914 multiple SC dose once every 2 weeks for 6 weeks Receives: Drug: ADX-914 |
| Placebo Comparator: Cohort 2:1- 2:3 | Placebo comparator | Placebo multiple SC dose once every 2 weeks for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Listing and summary of AE incidence
Measured: Screening to end of study, up to 18 weeks
Number of subjects with Physical exam findings
Listing of clinically significant changes in PE findings
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Screening to end of study, up to 18 weeks
Secondary outcomes (3)
Maximum observed plasma concentration, Cmax
Of ADX-914
Measured: Predose to Day 91 (SAD) and Day 127 (MAD)
Time to reach maximum observed plasma concentration, Tmax
Of ADX-914
Measured: Predose to Day 91 (SAD) and Day 127 (MAD)
Area Under the plasma concentration time curve, AUC
Of ADX-914
Measured: Predose to Day 91 (SAD) and Day 127 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start8 Sep 2020
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Q32 Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485481
- Sponsor's protocol ID
- ADX-914-001
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04485481
- Acronym / sponsor ID
- ADX-914-001
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Q32 Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cohort 1:1 - 1:6 ADX-914 | Experimental | Drug: ADX-914ADX-914 single SC dose |
| Placebo Comparator: Cohort 1:1 - 1:6 placebo | Placebo comparator | Drug: PlaceboPlacebo single SC dose |
| Experimental: Cohort 2:1- 2:3 | Experimental | Drug: ADX-914ADX-914 multiple SC dose once every 2 weeks for 6 weeks |
| Placebo Comparator: Cohort 2:1- 2:3 | Placebo comparator | Drug: PlaceboPlacebo multiple SC dose once every 2 weeks for 6 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-914Single dose from 0.1mg/kg to TBD | Drug | Experimental: Cohort 1:1 - 1:6 ADX-914 |
| PlaceboMatching single dose placebo | Drug | Placebo Comparator: Cohort 1:1 - 1:6 placebo |
| ADX-914Multiple dose from TBD to TBD | Drug | Experimental: Cohort 2:1- 2:3 |
| PlaceboMatching multiple dose placebo | Drug | Placebo Comparator: Cohort 2:1- 2:3 |
Primary outcome
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
3 secondary outcomes
Maximum observed plasma concentration, Cmax
Time frame: Predose to Day 91 (SAD) and Day 127 (MAD)
Time to reach maximum observed plasma concentration, Tmax
Time frame: Predose to Day 91 (SAD) and Day 127 (MAD)
Area Under the plasma concentration time curve, AUC
Time frame: Predose to Day 91 (SAD) and Day 127 (MAD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADX-914 in people with Safety Issues, run by Q32 Bio Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: Screening to end of study, up to 18 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.