A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function

This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Participants; Hepatic Impairment (HI)
• Intervention / Treatment: Drug: D-2570

Detailed Description

This is a single-center, non-randomized, open-label, parallel-controlled study designed to evaluate the pharmacokinetic profile and safety of D-2570 in participants with hepatic impairment and those with normal hepatic function. Participants with hepatic impairment will be enrolled first, followed by participants with normal hepatic function.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huan Zhou; Phone Number: +86 0552-3085747; Email: zhouhuanbest@vip.163.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical University
      • Contact: Huan Zhou; Phone Number: +86 0552-3085747; Email: zhouhuanbest@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Voluntarily participate in this study and sign the written informed consent form after full informed consent, and agree to comply with the procedures specified in the study protocol.
• Aged 18 to 70 years.
• Both males and females are eligible.
• Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
• Participants with normal hepatic function must have adequate hematologic, renal, and hepatic function.
• Have no plan to reproduce or donate sperm/eggs from screening until 30 days after the last dose of study drug, and agree to either completely abstain from sexual intercourse or use effective contraceptive measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.

Exclusion Criteria:

• Have undergone any prior surgery that may affect drug absorption, distribution, metabolism, or excretion, which, in the opinion of the investigator, would make the participant unsuitable for enrollment.
• Are female and currently lactating, or have a positive serum pregnancy test result at screening or during the study period.
• Have a known history of drug or substance abuse, or test positive for drugs of abuse on the urine drug screen.
• Have participated in another interventional clinical trial within 3 months prior to screening, or are currently participating in another clinical trial (participants who withdraw from a prior trial before treatment, i.e., were not randomized or did not receive study intervention, may be enrolled in this study).
• Have received a live vaccine within 2 months prior to study drug administration, or intend to receive a live vaccine during the study period.
• Have any other condition or finding that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-2570 Group 1	Drug: D-2570; D-2570 tablet, administered orally as a single dose
Experimental: D-2570 Group 2	Drug: D-2570; D-2570 tablet, administered orally as a single dose
Experimental: D-2570 Group 3	Drug: D-2570; D-2570 tablet, administered orally as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570	The main PK parameters -Time to maximum measured plasma concentration -Tmax	Up to 192 hours after the last dose
Maximum observed plasma concentration-Cmax	Maximum observed plasma concentration-Cmax	Up to 192 hours after the last dose
The main PK parameters Half-life -t1/2	The main PK parameters Half-life -t1/2	Up to 192 hours after the last dose
The main PK parameters#Area under the plasma concentration versus time curve-AUC	The main PK parameters#Area under the plasma concentration versus time curve-AUC	Up to 192 hours after the last dose
The main PK parameters-CL/F (apparent clearance)	The main PK parameters-CL/F (apparent clearance)	Up to 192 hours after the last dose
The main PK parameters-Vz/F (apparent volume of distribution)	The main PK parameters-Vz/F (apparent volume of distribution)	Up to 192 hours after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of adverse events	Up to Day9

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd
• Investigators: Principal Investigator: Huan Zhou, The First Affiliated Hospital of Bengbu Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 14, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: D2570-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No