ClinicalTrials.gg
RecruitingNCT07715175D2570-107Updated Oct 13, 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. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

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

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 13, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
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

In context

Renal Insufficiency

1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

InventisBio Co., Ltd is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntarily participate in this study after adequate , 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. (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 to the study drug or its ;
  • 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;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

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

06

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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 13, 2026
Sites
The First Affiliated Hospital of Anhui Medical University is now Recruiting
Oct 13, 2026
Start date
Aug 9, 2026→Aug 8, 2026 (actual)
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Not yet recruiting→Recruiting
    The First Affiliated Hospital of Anhui Medical University is now Recruiting
    Start date Aug 9, 2026→Aug 8, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07715175
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Aug 8, 2026
Primary completion
Nov 21, 2026 (estimated)
Completion
Nov 21, 2026 (estimated)
Last update
Oct 13, 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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Studies of the drug tested here: D-2570

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