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Not yet recruitingNCT07715175D2570-107Updated Jul 23, 2026

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

A Phase 1 interventional study of D-2570 in Renal Impairment, sponsored by InventisBio Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.

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

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Impairment

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Keywords

  • Renal Impairment
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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;
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    participants with normal renal function

    Subjects will receive a single dose of D-2570

    Drug: D-2570

  • Experimental
    participants with Mild Renal Impairment

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

    Drug: D-2570

  • Experimental
    participants with Moderate Renal Impairment

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

    Drug: D-2570

  • Experimental
    participants with Severe Renal Impairment

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

    Drug: D-2570

Interventions

  • DrugD-2570

    receive a single dose of D-2570

05

What researchers measure

Primary outcomes

  1. The main PK parameters -Time to maximum measured plasma concentration -Tmax

    The main PK parameters -Time to maximum measured plasma concentration -Tmax

    Time frame: Through study completion (approximately Day9)

  2. Maximum observed plasma concentration-Cmax

    Maximum observed plasma concentration-Cmax

    Time frame: Through study completion (approximately Day9)

  3. The main PK parameters Half-life -t1/2

    The main PK parameters Half-life -t1/2

    Time frame: Through study completion (approximately Day9)

  4. 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

    Time frame: Through study completion (approximately Day9)

  5. The main PK parameters-CL/F (apparent clearance)

    The main PK parameters-CL/F (apparent clearance)

    Time frame: Through study completion (approximately Day9)

  6. The main PK parameters-Vz/F (apparent volume of distribution)

    The main PK parameters-Vz/F (apparent volume of distribution)

    Time frame: Through study completion (approximately Day9)

  7. The cumulative excretion amount (Aeu)

    The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine

    Time frame: Through study completion (approximately Day9)

  8. The fraction of drug excreted in urine (Feu)

    The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine

    Time frame: Through study completion (approximately Day9)

  9. The renal clearance rate (CLR)

    The renal clearance rate (CLR)of D - 2570 and its metabolites in urine

    Time frame: Through study completion (approximately Day9)

Secondary outcomes

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

    Incidence of adverse events

    Time frame: Through study completion (approximately Day9)

06

Study locations

1 site
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230022, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07715175
Lead sponsor
InventisBio Co., Ltd
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Aug 9, 2026 (estimated)
Primary completion
Nov 21, 2026 (estimated)
Completion
Nov 21, 2026 (estimated)
Last update
Jul 23, 2026

Study contacts

Huan Zhou, Doctor
Contact
zhouhuanbest@vip.163.com
13665527160
Dingli Yao, Bachelor's
Contact
dingli.yao@inventisbio.com
15538261075
Huan Zhou, Doctor
principal investigator · The First Affiliated Hospital of Anhui Medical University

Oversight

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

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