Healthy Adult ParticipantsPhase 1NCT07715149
A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study testing D-2570 in people with Healthy Adult Participants and Hepatic Impairment (HI), run by InventisBio Co., Ltd at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Hepatic Impairment (HI)
- What is being tested?
- D-2570
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2026to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study and sign the written informed consent 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 contraceptive measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.
Who cannot join
- 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 live vaccine 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
Huan Zhou, +86 0552-3085747, zhouhuanbest@vip.163.com
About this study
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.
- Being tested
- D-2570
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-2570Drug
D-2570 tablet, administered orally as a single dose
| Study group | Role | What they receive |
|---|---|---|
| D-2570 Group 1 | Experimental | D-2570 Group 1 Receives: Drug: D-2570 |
| D-2570 Group 2 | Experimental | D-2570 Group 2 Receives: Drug: D-2570 |
| D-2570 Group 3 | Experimental | D-2570 Group 3 Receives: Drug: D-2570 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 192 hours after the last dose
Maximum observed plasma concentration-Cmax
Maximum observed plasma concentration-Cmax
Measured: Up to 192 hours after the last dose
The main PK parameters Half-life -t1/2
The main PK parameters Half-life -t1/2
Measured: Up to 192 hours after the last dose
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
Measured: Up to 192 hours after the last dose
The main PK parameters-CL/F (apparent clearance)
The main PK parameters-CL/F (apparent clearance)
Measured: Up to 192 hours after the last dose
The main PK parameters-Vz/F (apparent volume of distribution)
The main PK parameters-Vz/F (apparent volume of distribution)
Measured: Up to 192 hours after the last dose
Secondary outcomes (1)
Incidence of adverse events
Incidence of adverse events
Measured: Up to Day9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start17 Jul 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715149
- Sponsor's protocol ID
- D2570-106
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT07715149
- Acronym / sponsor ID
- D2570-106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| D-2570 Group 1 | Experimental | Drug: D-2570D-2570 Group 1 |
| D-2570 Group 2 | Experimental | Drug: D-2570D-2570 Group 2 |
| D-2570 Group 3 | Experimental | Drug: D-2570D-2570 Group 3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily participate in this study and sign the written informed consent 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.
Key exclusion criteria (6 listed)
- 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 live vaccine within 2 months prior to study drug administration, or intend to receive a live vaccine during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-2570D-2570 tablet, administered orally as a single dose | Drug | D-2570 Group 1, D-2570 Group 2, D-2570 Group 3 |
Primary outcome
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
Time frame: Up to 192 hours after the last dose
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Maximum observed plasma concentration-Cmax
Time frame: Up to 192 hours after the last dose
Maximum observed plasma concentration-Cmax
The main PK parameters Half-life -t1/2
Time frame: Up to 192 hours after the last dose
The main PK parameters Half-life -t1/2
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Time frame: Up to 192 hours after the last dose
The main PK parameters#Area under the plasma concentration versus time curve-AUC
The main PK parameters-CL/F (apparent clearance)
Time frame: Up to 192 hours after the last dose
The main PK parameters-CL/F (apparent clearance)
The main PK parameters-Vz/F (apparent volume of distribution)
Time frame: Up to 192 hours after the last dose
The main PK parameters-Vz/F (apparent volume of distribution)
1 secondary outcome
Incidence of adverse events
Time frame: Up to Day9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huan Zhou principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D-2570 in people with Healthy Adult Participants and Hepatic Impairment (HI), run by InventisBio Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Zhou (+86 0552-3085747, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570 (time frame: Up to 192 hours after the last dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.