Wuhan Createrna Science and Technology is sponsoring the first human clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of MY008211A, a potential drug candidate for paroxysmal nocturnal hemoglobinuria (PNH), in healthy participants.
The study started on May 27, 2022, and the estimated completion date is June 3, 2023.
The phase 1, randomized, double-blind, placebo-controlled, single-ascending dose clinical study has enrolled 46 participants aged 18 to 45 years. Participants were divided into 5 groups to receive different doses of MY008211A.
The primary endpoint to assess the safety and tolerability of MY008211A is the incidence and severity of adverse events for up to 21 days. In addition, researchers will determine the maximum plasma concentration of MY008211A tablets, the time to reach the maximum plasma concentration, the area under the concentration vs time curve, and the half-life of MY008211A, as well as changes from baseline in serum C3 and lactate dehydrogenase levels. These secondary outcome measures will be assessed for up to 72 hours after dosing.
Read more about PNH clinical trials
To be included in the study, participants had to have a minimum body weight of 50 kg for men or 45 kg for women and a body mass index between 19 and 26 kg/m2.
The study excluded individuals who were enrolled in another clinical trial or used a study drug within 3 months before MY008211A administration, as well as those who took any medicine or received a vaccine within 14 days before administration (or planned to receive a vaccine during the trial).
Moreover, it excluded patients with chronic or active gastrointestinal diseases or gastrointestinal surgery within 3 years prior to enrollment, definite diseases requiring medical intervention or that were not suitable for a clinical trial, a clear history of capsular microbial infection within 6 months before screening, a history of known or suspected immunodeficiency, a previous or current history of tuberculosis, an active systemic bacterial, viral, or fungal infection within 14 days before MY008211A administration, a history of relevant allergy, or a fever within 7 days before MY008211A administration.
Additional exclusion criteria applied to blood donors, drug abusers, smokers, heavy drinkers, pregnant or lactating women, and those planning to conceive. The detailed list of exclusion criteria can be found at ClinicalTrials.gov.
A study of single-dose MY008211A in healthy adults. ClinicalTrials.gov. December 8, 2022. Accessed December 27, 2022.