A Study on the Safety, Pharmacokinetics, and Food Effects of MI078 Capsules

NCT06982651 | Completed Phase 1

• 1 other identifier: 23090
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study was divided into three studies, namely, a single administration study, a food impact study, and a multiple administration study.

Conditions

Postpartum Depression

Keywords

Postpartum Depression; MI078; Minova

Outcome Measures

Primary Outcomes (6)

• Incidence, severity, and causality of AEs, SAEs

  Clinical safety assessments will be conducted for all spontaneously reported and directly observed adverse events (AEs) and serious adverse events (SAEs). AEs should also include abuse-related AEs (such as insomnia, sedation, hallucinations, tremors, and dissociative states) and withdrawal reactions (including headache, anxiety, nausea, vomiting, tremors, decreased attention, irritability, anger, and sleep disturbances).

  up to 72 hours after the last dose

• vital signs

  Any abnormal changes in vital signs

  up to 72 hours after the last dose

• SpO₂

  Any abnormal changes in SpO₂ (peripheral capillary oxygen saturation)

  up to 72 hours after the last dose

• 12-lead electrocardiogram (ECG)

  HR, RR interval, PR interval, QRS complex duration，QTcF=QT/(RR\^0.33)

  up to 72 hours after the last dose

• Modified Observer's Assessment of Alertness and Sedation Scale（MOAA/S）

  MOAA/S scale is a validated 6-point scale assessing the responsiveness of patients, coinciding with the American Society of Anesthesiologists (ASA) continuum of sedation。The scale rates patient responsiveness as follows： 5：Responds readily to name spoken in normal tone 4：Lethargic response to name spoken in normal tone 3：Responds only after name is called loudly and/or repeatedly 2：Responds only after mild prodding or shaking 1：Responds only after painful trapezius squeeze 0：Does not respond to painful trapezius squeeze

  up to 72 hours after the last dose

• Stanford Sleepiness Scale (SSS)

  The Stanford Sleepiness Scale (SSS) is a widely used self-assessment tool designed to measure subjective levels of sleepiness or alertness. It consists of a 7-point scale that allows individuals to rate their current level of alertness or sleepiness. The scale is as follows: 1. Feeling active, vital, alert, or wide awake 2. Functioning at a high level, but not at peak; able to concentrate 3. Awake, but relaxed; responsive but not fully alert 4. A little foggy; not at best 5. Foggy; losing interest in remaining awake; slowed down 6. Sleepy, woozy, fighting sleep; prefer to lie down 7. No longer fighting sleep, sleep onset soon; having dream-like thoughts

  up to 72 hours after the last dose

Secondary Outcomes (1)

• Plasma Concentrations of MI078

  up to 72 hours after the last dose

Study Arms (2)

MI078 capsule

EXPERIMENTAL

MI078 capsule

Drug: MI078

placebo

PLACEBO COMPARATOR

Placebo of MI078 Capsule

Drug: Placebo

Interventions

MI078 DRUG

Dosage Form: Capsule Specification: 25 mg Administration and Dosage: Oral. 1 capsule per dose, once daily. Duration of Treatment: 1 day Dosage Form: Capsule Specification: 50 mg Administration and Dosage: Oral. 1 capsule per dose, once daily. Duration of Treatment: 1 day Dosage Form: Capsule Specification: 200 mg Administration and Dosage: Oral. Options include: * 1 capsule per dose, once daily; * 2 capsules per dose, once daily; * 3 capsules per dose, once daily; * 4 capsules per dose, once daily; Duration of Treatment: 1 day . Dosage Form: Capsule Specification: 200 mg Administration and Dosage: Oral. Options include: * 1 capsule per dose, twice daily; * 2 capsules per dose, twice daily; Duration of Treatment: 7 days . Dosage Form: Capsule Specification: 50mg Administration and Dosage: Oral. Options include: \- 5 capsule per dose, Three times a day Duration of Treatment: 3 days .

MI078 capsule

Placebo DRUG

Placebo of MI078 Capsule

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits.
• Are an adult aged 18 to 45 years, inclusive.
• Have a BMI between 19.0 and 26.0 kg/m² (inclusive of boundary values) and weigh ≥50.0 kg if male, or ≥45.0 kg if female.
• Have a total score for suicidal ideation ≤12 points and a score for the dissimulation factor \<4 points on the suicide risk assessment scale at the time of screening.
• Have regular menstrual cycles, occurring within 28 ± 7 days (female volunteers only).
• Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery (if applicable).
• Are ≤9 months postpartum at Screening (if applicable).

You may not qualify if:

• Have a history or current diagnosis of any clinically significant diseases of the cardiovascular, endocrine, nervous, digestive, respiratory, urinary, and reproductive systems, hematology, immunology, psychiatry, or metabolic abnormalities, or any other diseases that may interfere with the study results.
• Have a family history of risk factors for torsades de pointes, or a history of short QT syndrome, long QT syndrome, unexplained sudden death or drowning in young age (≤40 years), or sudden infant death syndrome in first-degree relatives (i.e., biological parents, siblings, or children).
• Are engaged in high-altitude work or other occupations involving hazardous mechanical operations.
• Have a history of allergies to drugs, food, or other substances.
• Have experienced vomiting within 24 hours before dosing, which is assessed by the investigator to affect the study or impact the safety of the volunteer.
• Have undergone surgery within 4 weeks before the study or are planned to undergo surgery during the study period.
• Have taken any medications or health supplements (including traditional Chinese medicine) within 14 days before the study.
• Have used any drugs that inhibit or induce hepatic drug metabolism within 30 days before the study (e.g., inducers-barbiturates, carbamazepine, phenytoin, corticosteroids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines).
• Have participated in any clinical trial and taken any investigational drug within 3 months before the study.
• Have donated blood or experienced significant blood loss (≥200 mL, excluding menstrual blood loss in women), received blood transfusions, or used blood products within 3 months before enrollment.
• Are pregnant or breastfeeding, or cannot use one or more non-pharmacological contraceptive methods during the study period.
• Have special dietary requirements that prevent them from adhering to the standardized diet.
• Consume excessive amounts of tea, coffee, and/or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL).
• Have consumed excessive amounts of citrus-rich beverages or foods (e.g., grapefruit, oranges) within 48 hours before the first admission to the ward.
• Are smokers or have smoked more than 5 cigarettes per day within 3 months before the study or cannot refrain from using any tobacco products during the study.

Sponsors & Collaborators

• Nanjing Minova Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Third Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 21, 2025
• Study Start: September 9, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)