Condition: Paroxysmal Nocturnal Hemoglobinuria, PNH · Complement-mediated Kidney Disease · Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.
This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CMS-D017 capsules following single and multiple oral administrations in healthy Chinese adult participants. Both parts of the study are designed as randomized, double-blind, placebo-controlled, sequential cohort trials. Part 1 SAD plans to include 6 dose cohorts, with 8 participants per cohort (6 receiving CMS-D017 and 2 receiving placebo), for a total of 48 participants. Part 2 MAD plans to include 4 dose cohorts, with 10 participants per cohort (8 receiving CMS-D017 and 2 receiving placebo), for a total of 40 participants.
This description comes directly from the study's public registry record.
Yulan Chen · +86 10 6400 9673 · chenyulan@cms.net.cn
Le Peng · +86 0755-82416868-792 · pengle@cms.net.cn
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| Peking University Third Hospital | Beijing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07462780