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CompletedNCT05360628Updated Mar 1, 2023

Evaluation of PK and Safety of D-0120 and Allopurinol

An Early Phase 1 interventional study of D-0120 in combination with Allopurinol in Healthy, sponsored by InventisBio Co., Ltd. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by InventisBio Co., Ltd · Early Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Feb 2022, 4 years 7 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

InventisBio Co., Ltd is the lead sponsor of 32 studies on the registry; 10 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Significant medical history or current comorbidly determined by the Investigator.
  • Pregnant or nursing women
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    D-0120 plus Allopurinol

    D-0120 dosing followed by Allopurinol and combination treatment

    Drug: D-0120 in combination with Allopurinol

  • Experimental
    Allopurinol plus D-0120

    Allopurinol dosing followed by D-0120 and combination treatment

    Drug: D-0120 in combination with Allopurinol

Interventions

  • DrugD-0120 in combination with Allopurinol

    noted above

06

What researchers measure

Primary outcomes

  1. Type, incidence, severity and attribution of AEs.

    Evaluation of safety between D-0120 and Allopurinol

    Time frame: 14 days

  2. Plasma concentration of D-0120 and Allopurinol

    Evaluation of exposure between D-0120 and Allopurinol

    Time frame: 14 days

07

Study locations

1 site
  • Spaulding Clinical
    West Bend, Wisconsin 53095, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05360628
Lead sponsor
InventisBio Co., Ltd
Responsible party
Sponsor
First posted
May 4, 2022
Start date
Nov 1, 2021
Primary completion
Feb 10, 2022
Completion
Jul 23, 2022
Last update
Mar 1, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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