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

NCT07715175 | Not Yet Recruiting Phase 1

• 2 other identifiers: D2570-107CTR20261754
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Impairment

Keywords

Renal Impairment

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

  Through study completion (approximately Day9)

Study Arms (4)

participants with normal renal function

EXPERIMENTAL

Subjects will receive a single dose of D-2570

Drug: D-2570

participants with Mild Renal Impairment

EXPERIMENTAL

Subjects will receive a single dose of D-2570 (Part B)

Drug: D-2570

participants with Moderate Renal Impairment

EXPERIMENTAL

Subjects will receive a single dose of D-2570 (Part A)

Drug: D-2570

participants with Severe Renal Impairment

EXPERIMENTAL

Subjects will receive a single dose of D-2570 (Part A)

Drug: D-2570

Interventions

D-2570 DRUG

receive a single dose of D-2570

participants with Mild Renal Impairment; participants with Moderate Renal Impairment; participants with Severe Renal Impairment; participants with normal renal function

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Huan Zhou, Doctor

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Zhou, Doctor

CONTACT

13665527160; zhouhuanbest@vip.163.com

Dingli Yao, Bachelor's

CONTACT

15538261075; dingli.yao@inventisbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 9, 2026
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)