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NCT07715175
The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function.
Conditions: Renal Impairment
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: InventisBio Co., Ltd
Location: The First Affiliated Hospital of Anhui Medical University Hefei Anhui
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.
Eligibility Criteria
Inclusion Criteria:
* 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;
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 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;
Source: ClinicalTrials.gov (NCT07715175). StuddyBuddy aggregates publicly available trial information.