A Phase 1 interventional study of MY008211A tablets in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Wuhan Createrna Science and Technology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Wuhan Createrna Science and Technology Co., Ltd · Phase 1, Interventional, and Treatment
This was a single-center, single-dose, open-label clinical study. 12 subjects were randomly assigned in a 1:1 ratio to one of the following dosing sequences (sequence 1: AB; Sequence 2: BA). Each dosing sequence consisted of two cycles, one dose per cycle, with a 5-day washout period between doses.
A: A single dose of MY008211A tablets was administered in the fasting state (fasting for at least 10 h with water as needed).
B: A single dose of MY008211A tablets was administered after a standard high-fat, high-calorie fed.
192 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
This study's enrollment of 12 is below the median of 34 across 150 interventional studies indexed under Hemoglobinuria, Paroxysmal.
Browse Hemoglobinuria, Paroxysmal studies →Wuhan Createrna Science and Technology Co., Ltd is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
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6 subjects were given a single dose of MY008211A tablets in the fasting state and, after a 5-day washout period, a single dose of MY008211A tablet was administered after taking a standard high-fat and high-calorie fed.
Drug: MY008211A tablets
6 subjects were given a single dose of MY008211A tablet after taking a standard high-fat and high-calorie fed and, after a 5-day washout period, a single dose of MY008211A tablet in the fasting state.
Drug: MY008211A tablets
A single dose of MY008211A tablet was administered after fasting and high-fat, high-calorie feeding
Also known as: no other name
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax) Of MY008211A tablets
Time frame: up to 72 hours postdose
The Maximum Plasma Concentration (Tmax)
Time To Reach The Maximum Plasma Concentration (Tmax) Of MY008211A
Time frame: up to 72 hours postdose
Area Under The Concentration Versus Time Curve (AUC)
Area Under The Concentration Versus Time Curve (AUC) Of MY008211A
Time frame: up to 72 hours postdose
The incidence and severity of adverse events to assess safety and tolerability
such as laboratory abnormalities
Time frame: up to 9 days
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Oct 2022, 0 months.
Of 17 phase 1 interventional studies under Hemoglobinuria, Paroxysmal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lanoracopan
Wuhan Createrna Science and Technology Co., Ltd