Healthy VolunteersPhase 1NCT04314986
Multiple Ascending Dose Study of AR882 in Healthy Adult Male Volunteers
A Phase 1 study of Healthy Volunteers, run by Arthrosi Therapeutics at 1 site in Australia.
Trial summary
A study to assess multiple ascending doses of AR882 in healthy adult males. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Jun 2019to 18 Sep 2019
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and < 9 mg/dL (535 µmol/L)
- Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
- Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures
Who cannot join
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- History of cardiac abnormalities
- History and/or presence of drug addiction or excessive use of alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
A study to assess multiple ascending doses of AR882 in healthy adult males.
- Conditions
- Healthy Volunteers
- Being tested
- Cohort 1: AR882 or placebo, Cohort 2: AR882 or placebo, Cohort 3: AR882 or placebo, Cohort 4: AR882 or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1: AR882 or placeboDrug
AR882 or matching placebo administered once daily for 10 days
Cohort 2: AR882 or placeboDrug
AR882 or matching placebo administered once daily for 10 days.
Cohort 3: AR882 or placeboDrug
AR882 or matching placebo administered once daily for 10 days
Cohort 4: AR882 or placeboDrug
AR882 or matching placebo administered once daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| AR882 (Dose A) | Experimental | Not described Receives: Drug: Cohort 1: AR882 or placebo |
| AR882 (Dose B) | Experimental | Not described Receives: Drug: Cohort 2: AR882 or placebo |
| AR882 (Dose C) | Experimental | Not described Receives: Drug: Cohort 3: AR882 or placebo |
| AR882 (Dose D) | Experimental | Not described Receives: Drug: Cohort 4: AR882 or placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Cohort 1: AR882 or placebo; Drug: Cohort 2: AR882 or placebo; Drug: Cohort 3: AR882 or placebo; Drug: Cohort 4: AR882 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety profile of AR882 based on incidence of adverse events
Incidence of adverse events following multiple doses of AR882
Measured: 22 Days
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Incidence of abnormal laboratory findings following multiple doses of AR882
Measured: 22 Days
To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings
Incidence of abnormal electrocardiogram findings following multiple doses of AR882
Measured: 22 Days
To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings
Incidence of abnormal vital signs findings following multiple doses of AR882
Measured: 22 Days
Area under the curve (AUC) for plasma AR882
Profile from plasma in terms of AUC following multiple doses of AR882
Measured: 15 Days
Time to maximum plasma concentration (Tmax) for AR882
Profile from plasma in terms of Tmax following multiple doses of AR882
Measured: 15 Days
Maximum plasma concentration (Cmax) for AR882
Profile from plasma in terms of Cmax following multiple doses of AR882
Measured: 15 Days
Apparent terminal half-life (t1/2) for AR882
Profile from plasma in terms of t1/2 following multiple doses of AR882
Measured: 15 Days
Amount excreted (Ae) into urine for AR882
Profile from urine in terms of Ae following multiple doses of AR882
Measured: 15 Days
Fractional Excretion (FEUA) for AR882
Profile from urine in terms of FEUA following multiple doses of AR882
Measured: 15 Days
Secondary outcomes (1)
PD profile following multiple doses of AR882
Profile from serum uric acid concentrations over time
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start28 Jun 2019
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrosi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314986
- Sponsor's protocol ID
- AR882-102
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT04314986
- Acronym / sponsor ID
- AR882-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 19 Mar 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 study to assess multiple ascending doses of AR882 in healthy adult males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AR882 (Dose A) | Experimental | Drug: Cohort 1: AR882 or placebo |
| AR882 (Dose B) | Experimental | Drug: Cohort 2: AR882 or placebo |
| AR882 (Dose C) | Experimental | Drug: Cohort 3: AR882 or placebo |
| AR882 (Dose D) | Experimental | Drug: Cohort 4: AR882 or placebo |
| Placebo | Placebo comparator | Drug: Cohort 1: AR882 or placebo, Drug: Cohort 2: AR882 or placebo, Drug: Cohort 3: AR882 or placebo, Drug: Cohort 4: AR882 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Screening serum uric acid level ≥ 4.5 mg/dL (268 µmol/L) and < 9 mg/dL (535 µmol/L)
- Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
- Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures
Key exclusion criteria (3 listed)
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- History of cardiac abnormalities
- History and/or presence of drug addiction or excessive use of alcohol
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 |
|---|---|---|
| Cohort 1: AR882 or placeboAR882 or matching placebo administered once daily for 10 days | Drug | AR882 (Dose A), Placebo |
| Cohort 2: AR882 or placeboAR882 or matching placebo administered once daily for 10 days. | Drug | AR882 (Dose B), Placebo |
| Cohort 3: AR882 or placeboAR882 or matching placebo administered once daily for 10 days | Drug | AR882 (Dose C), Placebo |
| Cohort 4: AR882 or placeboAR882 or matching placebo administered once daily for 10 days | Drug | AR882 (Dose D), Placebo |
Primary outcome
To evaluate the safety profile of AR882 based on incidence of adverse events
Time frame: 22 Days
Incidence of adverse events following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
Time frame: 22 Days
Incidence of abnormal laboratory findings following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal electrocardiogram findings
Time frame: 22 Days
Incidence of abnormal electrocardiogram findings following multiple doses of AR882
To evaluate the safety profile of AR882 based on incidence of abnormal vital signs findings
Time frame: 22 Days
Incidence of abnormal vital signs findings following multiple doses of AR882
Area under the curve (AUC) for plasma AR882
Time frame: 15 Days
Profile from plasma in terms of AUC following multiple doses of AR882
Time to maximum plasma concentration (Tmax) for AR882
Time frame: 15 Days
Profile from plasma in terms of Tmax following multiple doses of AR882
Maximum plasma concentration (Cmax) for AR882
Time frame: 15 Days
Profile from plasma in terms of Cmax following multiple doses of AR882
Apparent terminal half-life (t1/2) for AR882
Time frame: 15 Days
Profile from plasma in terms of t1/2 following multiple doses of AR882
Amount excreted (Ae) into urine for AR882
Time frame: 15 Days
Profile from urine in terms of Ae following multiple doses of AR882
Fractional Excretion (FEUA) for AR882
Time frame: 15 Days
Profile from urine in terms of FEUA following multiple doses of AR882
1 secondary outcome
PD profile following multiple doses of AR882
Time frame: 15 Days
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 16 Nov 2020.
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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 of Healthy Volunteers, run by Arthrosi Therapeutics 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 3 inclusion and 3 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 16 Nov 2020. 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?
To evaluate the safety profile of AR882 based on incidence of adverse events (time frame: 22 Days). The study lists 10 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 16 Nov 2020.