Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 11:53 AM
Study NCT ID:
NCT06982651
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Safety, Pharmacokinetics, and Food Effects of MI078 Capsules
Sponsor:
Nanjing Minova Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Parallel-Controlled Phase Ⅰ Clinical Trial of the Tolerability, Safety, Pharmacokinetics and Food Effects of MI078 Capsules in Single and Multiple Doses in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was divided into three studies, namely, a single administration study, a food impact study, and a multiple administration study.
Detailed Description:
Single-dose study：Eight single-dose cohorts (25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, and 1000mg) were planned, as described in the table below. In the first and second dose groups (25 mg and 50 mg), a single oral dose of MI078 capsules was given to 1 male and 2 females in a single-center, open-label design. The tolerance and safety of MI078 capsules were evaluated. Dose groups 3-8 were designed in a single-center, randomized, double-blind, placebo-controlled design. Each dose group was planned to enroll 8-10 volunteers, half male and half female (see the table below for details). On the basis of PK and safety data, the actual dose escalation could be adjusted accordingly.
Food Impact Studies：This study adopted a randomized, open, two-sequence, two-cycle crossover design, and the 400 mg dose was selected for the food impact test. Fourteen healthy volunteers, both male and female, were randomly divided into two sequence groups according to the fasting - postprandial and postprandial - fasting administration methods. Each sequence group had 7 volunteers and was divided into two cycles. All volunteers were required to be hospitalized from 1 day before administration to 72 h after administration (day 4). During this hospitalization, volunteers were required to complete the collection of pharmacokinetic samples (blood samples, collection to 72 h after administration). All volunteers could be discharged after the collection of the above biological samples and the corresponding safety assessment. After a washing period of at least 7 days, the second cycle of PK test could be carried out. The collection of PK blood samples and the corresponding safety check in the second cycle were the same as those in the first cycle.
Multiple dosing studies：The multiple-dose study was a single-center, multi-dose, randomized, double-blind, placebo-controlled design. A total of 30 healthy volunteers (half male and half female) were planned to be enrolled. When the higher-dose arm of the single-dose study had been evaluated for tolerability, the multiple-dose study with a sublower dose could proceed. The dose for this study could be adjusted to 250mg for group 3 based on safety and PK data (blinded) from the completed study results (200mg and 400mg groups). MI078 capsules or placebo were administered to 10 volunteers in each of three dose cohorts.
Food Impact Studies：This study adopted a randomized, open, two-sequence, two-cycle crossover design, and the 400 mg dose was selected for the food impact test. Fourteen healthy volunteers, both male and female, were randomly divided into two sequence groups according to the fasting - postprandial and postprandial - fasting administration methods. Each sequence group had 7 volunteers and was divided into two cycles. All volunteers were required to be hospitalized from 1 day before administration to 72 h after administration (day 4). During this hospitalization, volunteers were required to complete the collection of pharmacokinetic samples (blood samples, collection to 72 h after administration). All volunteers could be discharged after the collection of the above biological samples and the corresponding safety assessment. After a washing period of at least 7 days, the second cycle of PK test could be carried out. The collection of PK blood samples and the corresponding safety check in the second cycle were the same as those in the first cycle.
Multiple dosing studies：The multiple-dose study was a single-center, multi-dose, randomized, double-blind, placebo-controlled design. A total of 30 healthy volunteers (half male and half female) were planned to be enrolled. When the higher-dose arm of the single-dose study had been evaluated for tolerability, the multiple-dose study with a sublower dose could proceed. The dose for this study could be adjusted to 250mg for group 3 based on safety and PK data (blinded) from the completed study results (200mg and 400mg groups). MI078 capsules or placebo were administered to 10 volunteers in each of three dose cohorts.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: