Evaluation of PK and Safety of D-0120 and Allopurinol

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: D-0120 in combination with Allopurinol

• Registration Number: NCT05360628
• Lead Sponsor: InventisBio Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-01
• Primary Completion: 2022-02-10
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Study Completion: 2022-07-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-0120 plus Allopurinol	D-0120 in combination with Allopurinol	D-0120 dosing followed by Allopurinol and combination treatment
Allopurinol plus D-0120	D-0120 in combination with Allopurinol	Allopurinol dosing followed by D-0120 and combination treatment

Primary Outcome Measures

Name	Time	Method
Type, incidence, severity and attribution of AEs.	14 days	Evaluation of safety between D-0120 and Allopurinol
Plasma concentration of D-0120 and Allopurinol	14 days	Evaluation of exposure between D-0120 and Allopurinol

Trial Locations

Locations (1)

Spaulding Clinical; 🇺🇸 West Bend, Wisconsin, United States