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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInventisBio Co., Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • D-2570

    Drug

    receive a single dose of D-2570

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: participants with normal renal functionExperimental treatment 1 intervention
Group B: participants with Mild Renal ImpairmentExperimental treatment 1 intervention
Group C: participants with Moderate Renal ImpairmentExperimental treatment 1 intervention
Group D: participants with Severe Renal ImpairmentExperimental treatment 1 intervention

Trial outcomes

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)

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.