Postpartum DepressionPhase 1NCT06982651
A Study on the Safety, Pharmacokinetics, and Food Effects of MI078 Capsules
A Phase 1 study testing MI078 in people with Postpartum Depression, run by Nanjing Minova Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study was divided into three studies, namely, a single administration study, a food impact study, and a multiple administration study. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- MI078
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2023to 18 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- Are alcohol abusers or have regularly consumed alcohol within 6 months before the study (i.e., more than 14 units of alcohol per week, 1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) or cannot refrain from using any alcohol-containing products during the study.
- Are drug abusers or have used soft drugs (e.g., marijuana) within 3 months before the study or hard drugs (e.g., cocaine, phencyclidine) within 1 year before the study.
- Have abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; pulse rate <50 bpm or >100 bpm, respiratory rate <12 breaths per minute or >20 breaths per minute) or abnormal physical examination, electrocardiogram (normal ECG requirements: male QTcF ≤450 ms, female QTcF ≤470 ms; PR interval ≤200 ms; QRS complex duration ≤120 ms), or laboratory tests with clinically significant abnormalities (as judged by the clinical research physician).
- Have positive results for hepatitis B surface antigen, hepatitis C antibody, preliminary screening for HIV antigen/antibody, or syphilis serological reaction.
- Have difficult venous blood collection or a history of needle fainting or blood fainting, who are deemed unsuitable for enrollment by the investigator.
- Are likely to be unable to complete the study for other reasons or are deemed ineligible by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Xiangya Hospital, Central South University
Changsha, Hunan, 410013
About this study
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
This study was divided into three studies, namely, a single administration study, a food impact study, and a multiple administration study.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- MI078, Placebo
- Keywords
- Postpartum Depression, MI078, Minova
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI078Drug
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 .
PlaceboDrug
Placebo of MI078 Capsule
| Study group | Role | What they receive |
|---|---|---|
| MI078 capsule | Experimental | MI078 capsule Receives: Drug: MI078 |
| placebo | Placebo comparator | Placebo of MI078 Capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 72 hours after the last dose
vital signs
Any abnormal changes in vital signs
Measured: up to 72 hours after the last dose
SpO₂
Any abnormal changes in SpO₂ (peripheral capillary oxygen saturation)
Measured: 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)
Measured: 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
Measured: 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:
- Feeling active, vital, alert, or wide awake
- Functioning at a high level, but not at peak; able to concentrate
- Awake, but relaxed; responsive but not fully alert
- A little foggy; not at best
- Foggy; losing interest in remaining awake; slowed down
- Sleepy, woozy, fighting sleep; prefer to lie down
- No longer fighting sleep, sleep onset soon; having dream-like thoughts
Measured: up to 72 hours after the last dose
Secondary outcomes (1)
Plasma Concentrations of MI078
PK Parameters of MI078 will be assessed.
Measured: up to 72 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start9 Sep 2023
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Minova Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982651
- Sponsor's protocol ID
- 23090
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06982651
- Acronym / sponsor ID
- 23090
- Conditions
- Postpartum Depression
- Keywords
- Postpartum Depression, MI078, Minova
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Nanjing Minova Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI078 capsule | Experimental | Drug: MI078MI078 capsule |
| placebo | Placebo comparator | Drug: PlaceboPlacebo of MI078 Capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI078Dosage 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 . | Drug | MI078 capsule |
| PlaceboPlacebo of MI078 Capsule | Drug | placebo |
Primary outcome
Incidence, severity, and causality of AEs, SAEs
Time frame: up to 72 hours after the last dose
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).
vital signs
Time frame: up to 72 hours after the last dose
Any abnormal changes in vital signs
SpO₂
Time frame: up to 72 hours after the last dose
Any abnormal changes in SpO₂ (peripheral capillary oxygen saturation)
12-lead electrocardiogram (ECG)
Time frame: up to 72 hours after the last dose
HR, RR interval, PR interval, QRS complex duration，QTcF=QT/(RR^0.33)
Modified Observer's Assessment of Alertness and Sedation Scale（MOAA/S）
Time frame: up to 72 hours after the last dose
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
Stanford Sleepiness Scale (SSS)
Time frame: up to 72 hours after the last dose
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
1 secondary outcome
Plasma Concentrations of MI078
Time frame: up to 72 hours after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MI078 in people with Postpartum Depression, run by Nanjing Minova Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and causality of AEs, SAEs (time frame: up to 72 hours after the last dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.