HealthyEarly Phase 1NCT05360628
Evaluation of PK and Safety of D-0120 and Allopurinol
A Early Phase 1 study testing D-0120 in combination with Allopurinol in people with Healthy, run by InventisBio Co., Ltd at 1 site in United States.
Trial summary
Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- D-0120 in combination with Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 23 Jul 2022
- Phase
- Early 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects between the ages of 18-55
- Required evaluation by Investigator for screening and enrollment
- Agreement and compliance with the study and follow-up procedures
Who cannot join
- Significant medical history or current comorbidly determined by the Investigator.
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic Interactions Between D-0120 and Allopurinol in Healthy Adult Subjects
Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects
- Conditions
- Healthy
- Being tested
- D-0120 in combination with Allopurinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0120 in combination with AllopurinolDrug
noted above
| Study group | Role | What they receive |
|---|---|---|
| D-0120 plus Allopurinol | Experimental | D-0120 dosing followed by Allopurinol and combination treatment Receives: Drug: D-0120 in combination with Allopurinol |
| Allopurinol plus D-0120 | Experimental | Allopurinol dosing followed by D-0120 and combination treatment Receives: Drug: D-0120 in combination with Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence, severity and attribution of AEs.
Evaluation of safety between D-0120 and Allopurinol
Measured: 14 days
Plasma concentration of D-0120 and Allopurinol
Evaluation of exposure between D-0120 and Allopurinol
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Nov 2021
- Primary completion10 Feb 2022
- Study completion23 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- D0120 Allopurinol
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360628
- Sponsor's protocol ID
- D0120-104
- Status last verified
- Feb 2023
- First submitted
- 1 Nov 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic Interactions Between D-0120 and Allopurinol in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05360628
- Acronym / sponsor ID
- D0120-104
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 23 Jul 2022 (actual)
- First posted
- 4 May 2022 (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.
Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- D0120 Allopurinol
| Arm | Type | Receives |
|---|---|---|
| D-0120 plus Allopurinol | Experimental | Drug: D-0120 in combination with AllopurinolD-0120 dosing followed by Allopurinol and combination treatment |
| Allopurinol plus D-0120 | Experimental | Drug: D-0120 in combination with AllopurinolAllopurinol dosing followed by D-0120 and combination treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects between the ages of 18-55
- Required evaluation by Investigator for screening and enrollment
- Agreement and compliance with the study and follow-up procedures
Key exclusion criteria (2 listed)
- Significant medical history or current comorbidly determined by the Investigator.
- Pregnant or nursing women
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 |
|---|---|---|
| D-0120 in combination with Allopurinolnoted above | Drug | Allopurinol plus D-0120, D-0120 plus Allopurinol |
Primary outcome
Type, incidence, severity and attribution of AEs.
Time frame: 14 days
Evaluation of safety between D-0120 and Allopurinol
Plasma concentration of D-0120 and Allopurinol
Time frame: 14 days
Evaluation of exposure between D-0120 and Allopurinol
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 1 Mar 2023.
- 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 Early Phase 1 study testing D-0120 in combination with Allopurinol in people with Healthy, run by InventisBio Co., Ltd at 1 site in United States.
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 2 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 1 Mar 2023. 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 United States. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Type, incidence, severity and attribution of AEs. (time frame: 14 days). The study lists 2 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 1 Mar 2023.