The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function. (D2570-107)

A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function

This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: D-2570

Detailed Description

Subjects of this study will be admitted to the Phase I ward of the research center one day before drug administration . On the first day, subjects will orally take a single dose of D-2570. The researchers will collect a series of blood and urine samples before and after drug D - 2570 administration to determine the drug concentration and evaluate the pharmacokinetic characteristics. The subjects can leave site after completing the safety evaluation.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huan Zhou, Doctor; Phone Number: 13665527160; Email: zhouhuanbest@vip.163.com
• Study Contact Backup: Name: Dingli Yao, Bachelor's; Phone Number: 15538261075; Email: dingli.yao@inventisbio.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Huan Zhou, Doctor; Phone Number: 13665527160; 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 after adequate informed consent, sign the written informed consent form, and agree to comply with all procedures specified in the study protocol;
• Aged 18 to 70 years (inclusive). Age matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 years;
• Male and female participants are eligible. Gender matching will be performed between the normal renal function group and the matched renal impairment group with a difference of no more than 1 subject;
• Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) = weight (kg) / height squared (m²), ranging from 19 to 30 kg/m² (inclusive). Weight matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 kg;

Exclusion Criteria:

• Allergic constitution (e.g., allergy to pollen, two or more types of drugs/foods), or history of atopic diseases such as asthma and urticaria, or known hypersensitivity to the study drug or its excipients;
• Positive T-SPOT result at screening. Combined with clinical signs and chest posteroanterior X-ray findings, the participant is judged by the investigator to have active pulmonary tuberculosis;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: participants with normal renal function; Subjects will receive a single dose of D-2570	Drug: D-2570; receive a single dose of D-2570
Experimental: participants with Mild Renal Impairment; Subjects will receive a single dose of D-2570 (Part B)	Drug: D-2570; receive a single dose of D-2570
Experimental: participants with Moderate Renal Impairment; Subjects will receive a single dose of D-2570 (Part A)	Drug: D-2570; receive a single dose of D-2570
Experimental: participants with Severe Renal Impairment; Subjects will receive a single dose of D-2570 (Part A)	Drug: D-2570; receive a single dose of D-2570

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	The main PK parameters -Time to maximum measured plasma concentration -Tmax	Through study completion (approximately Day9)
Maximum observed plasma concentration-Cmax	Maximum observed plasma concentration-Cmax	Through study completion (approximately Day9)
The main PK parameters Half-life -t1/2	The main PK parameters Half-life -t1/2	Through study completion (approximately Day9)
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	Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)	The main PK parameters-CL/F (apparent clearance)	Through study completion (approximately Day9)
The main PK parameters-Vz/F (apparent volume of distribution)	The main PK parameters-Vz/F (apparent volume of distribution)	Through study completion (approximately Day9)
The cumulative excretion amount (Aeu)	The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine	Through study completion (approximately Day9)
The fraction of drug excreted in urine (Feu)	The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine	Through study completion (approximately Day9)
The renal clearance rate (CLR)	The renal clearance rate (CLR)of D - 2570 and its metabolites in urine	Through study completion (approximately Day9)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0	Incidence of adverse events	Through study completion (approximately Day9)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 9, 2026
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 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 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Renal Impairment
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: D2570-107; CTR20261754 (Other Identifier: Clinicaltrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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