104
Participants
Start Date
May 9, 2024
Primary Completion Date
December 31, 2024
Study Completion Date
February 28, 2025
ND-003 40mg
Participants receive 40mg ND-003 tablets once.
ND-003 placebo 40mg
Participants receive placebo tablet matching to receive 40mg of ND-003.
ND-003 80mg
Participants receive 80mg ND-003 tablets once.
ND-003 placebo 80mg
Participants receive placebo tablet matching to receive 80mg of ND-003.
ND-003 160mg
Participants receive 160mg ND-003 tablets once.
ND-003 placebo 160mg
Participants receive placebo tablet matching to receive 160mg of ND-003.
ND-003 240mg
Participants receive 240mg ND-003 tablets once.
ND-003 placebo 240mg
Participants receive placebo tablet matching to receive 240mg of ND-003.
ND-003 300mg
Participants receive 300mg ND-003 tablets once.
ND-003 placebo 300mg
Participants receive placebo tablet matching to receive 300mg of ND-003.
MAD_ND003_Dose 1
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
MAD_placebo_Dose 1
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 1
MAD_ND003_Dose 2
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
MAD_placebo_Dose 2
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 2
MAD_ND003_Dose 3
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
MAD_ placebo_Dose 3
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 3
Food effect_Cohort 1
Firstly orally administrated ND-003 tablets in fast state and then in fed state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.
Food effect_Cohort 2
Firstly orally administrated ND-003 tablets in fed state and then in fast state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.
Union Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan
Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
UNKNOWN
Shenzhen NewDEL Biotech, Co., Ltd
INDUSTRY