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

Trial statusNot yet recruiting
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

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

Treatments tested in this trial

  • D-2570

Treatment groups

40 Participants
are divided into 4 treatment groups

Sponsors and collaborators