ClinicalTrials.gg
RecruitingNCT07715149Updated Sep 23, 2026

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

A Phase 1 interventional study of D-2570 in Healthy Adult Participants and Hepatic Impairment (HI), 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 2026-09-23.

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

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy Adult Participants
  • Hepatic Impairment (HI)
03

In context

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 and sign the written 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 measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.

Exclusion criteria

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 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.
Terms in these criteria, in plain language(3)

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

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

Study arms

  • Experimental
    D-2570 Group 1

    D-2570 Group 1

    Drug: D-2570

  • Experimental
    D-2570 Group 2

    D-2570 Group 2

    Drug: D-2570

  • Experimental
    D-2570 Group 3

    D-2570 Group 3

    Drug: D-2570

Interventions

  • DrugD-2570

    D-2570 tablet, administered orally as a single dose

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 192 hours after the last dose

  2. Maximum observed plasma concentration-Cmax

    Maximum observed plasma concentration-Cmax

    Time frame: Up to 192 hours after the last dose

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

    The main PK parameters Half-life -t1/2

    Time frame: Up to 192 hours after the last dose

  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: Up to 192 hours after the last dose

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

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

    Time frame: Up to 192 hours after the last dose

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

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

    Time frame: Up to 192 hours after the last dose

Secondary outcomes

  1. Incidence of adverse events

    Incidence of adverse events

    Time frame: Up to Day9

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Oct 2026, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2026
First posted
Jul 20, 2026
StartActual
Jul 17, 2026
Primary completionEst.
Oct 31, 2026
CompletionEst.
Nov 30, 2026
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07715149
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Jul 17, 2026
Primary completion
Oct 31, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Sep 23, 2026

Study contacts

Huan Zhou
Contact
zhouhuanbest@vip.163.com
+86 0552-3085747
Huan Zhou
principal investigator · The First Affiliated Hospital of Bengbu 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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