Testing D-2570 in adults with varying kidney function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial has two parts: Part A with 24 participants and Part B with 16 participants. Participants are admitted the day before dosing, receive a single oral dose of D-2570, and have blood and urine collected to characterize pharmacokinetics. Safety evaluations determine whether participants can complete the study. The trial compares individuals with normal renal function to those with renal impairment to understand how kidney function affects drug exposure.

Why it matters

Who can join: the full rules

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;

Where it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Huan Zhou, Doctor — The First Affiliated Hospital of Anhui Medical University
• Study coordinator: Huan Zhou, Doctor
• Email: zhouhuanbest@vip.163.com
• Phone: 13665527160

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.