This trial is a multi dose, randomized, double-blind, placebo-controlled, single center Phase I clinical study. The purpose of this study is to evaluate the safety, tolerability, and PK characteristics of Deuteromide Hydrobromide for Suspension administered multiple times in healthy volunteers.
Two groups are initially set up, starting from Group 1 and progressing sequentially to Group 2. After all volunteers in the first group (900 mg BID group) complete the safety follow-up on the 4th day after the last dose (i.e. D10), the safety information and PK data will be reviewed jointly by the researchers and sponsors before the second group of volunteers starting administration. The preferred dose for the second group is 900 mg TID, and if there are safety risks found after the Group 1 study, it will be adjusted to 1200 mg BID or other appropriate dosage and frequency. A total of 24 volunteers are planned to be enrolled, with 12 volunteers in each group. The trial drug and placebo will be allocated in a 3:1 ratio, with 9 volunteers in each group receiving the trial drug and 3 volunteers receiving placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day
Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, twice a day Experimental: Deuremidevir Hydrobromide for Suspension 900mg group, 3 times a day Experimental: Deuremidevir Hydrobromide for Suspension 1200mg group, twice a day
Hushan Hospital Fudan university
Shanghai, Shanghai Municipality, China
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Time frame: From Day1 to Day10 after administration
Cmax
maximum observed plasma concentration
Time frame: 168 hours after administration
Tmax
time at which Cmax occurs
Time frame: 168 hours after administration
AUC0- t
area under the plasma concentration time curve from time zero to the last quantifiable concentration
Time frame: 168 hours after administration
AUC0-∞
area under the plasma concentration time curve from time zero to infinity
Time frame: 168 hours after administration
t1/2
terminal half life
Time frame: 168 hours after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.