DepressionPhase 1NCT07324408
Multiple Ascending Dose Study of NH102 in Healthy Subjects
A Phase 1 study testing NH102 in people with Depression, run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of NH102 when administered as multiple oral dose at escalating dose levels in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- NH102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 10 Apr 2023
- 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
- Subjects aged between 18 and 45 (both inclusive) years old when signing the informed consent.
- Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18.5 and ≤28 kg/m2 at screening.
- Subjects voluntarily participate and sign the informed consent after understanding the purpose, content, procedures and possible risks of the trial.
- The subjects will be able to communicate well with the investigators, be willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the study.
Who cannot join
- The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
- There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
- Subjects with past history of allergy to drugs or allergic disease.
- Subjects with currently or past history of mental disorders and brain functional disorders.
- According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
- Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior.
Show all 19Show fewer
- Subjects have history of alcohol abuse(i.e.,criteria are per week consumption more than 14 standard units(1 unit =360mL beer or 45mL 40% alcohol of Chinese liquor or 150mL wine)or positive alcohol breath tests at screening within 1 year prior.
- Average amount of daily smoking>5 cigarettes at screening 3 months prior.
- Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing.
- Female subjects who are pregnant and lactating ; and those who refuse to use effective non-drug contraceptive measures (such as abstinence, intrauterine device) or have planned to donate sperm or ovum throughout the study period and within 3 months after the end of the study.
- Abnormal vital signs, lab and ECG indicators, as determined by the researcher, and clinically significant (e.g., male QTC > 450ms female > 470ms,corrected by Friericia ).
- Subjects who resting heart rate <55 beats/min or >100 beats/min; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg.
- Subjects who hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or HIV antibody (HIV-Ab), or syphilis serum reaction (TRUST) is non-negative.
- Subjects who participated in any clinical trial within 3 months before medication.
- Subjects have history of blood donations of 400 mL within 3 months before enrollment; 200 mL within 1 month before enrollment; or have history of using blood products.
- Subjects who had a history of surgery within 3 months prior to enrollment, or did not recover from surgery, or had an expected surgical plan during the study period.
- Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment.
- Subjects who directly related to this clinical trial.
- Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 201108
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiply Ascending Dose of NH102 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of NH102 when administered as multiple oral dose at escalating dose levels in healthy participants.
Read the detailed description
The drug being tested in this study is called NH102. NH102 is being tested to treat people who have depression. This study will look at the safety, tolerability and PK of NH102 in healthy participants.
The study may enroll up to 30-40 participants. Participants will be randomly assigned within each cohort to receive NH102 or placebo which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need). The study consists of four dose groups: 3 mg (fixed dose), 10 mg (fixed dose), 15 mg (starting at 6 mg, then escalated to 10 mg, and finally to 15 mg), and 20 mg (starting at 10 mg, then escalated to 15 mg, and finally to 20 mg). Each group enrolls 10 subjects, with 8 receiving NH102 and 2 receiving placebo. For the third and fourth dose groups (15 mg and 20 mg) that follow a titration dosing regimen, each includes 2 sentinel subjects (both male). The two sentinel subjects may be dosed simultaneously. Only after both sentinel subjects complete all 17 doses (with a single dose administered on Day 9) and are observed for at least 24 hours, along with preliminary confirmation of safety, may the remaining subjects in the same dose group proceed with dosing.
- Conditions
- Depression
- Being tested
- NH102, Placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NH102Drug
tables orally
PlaceboDrug
tables orally
| Study group | Role | What they receive |
|---|---|---|
| NH102 3mg | Experimental | NH102 3mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). The morning doses on D1 and D7 (around 8:00 AM) are to be given under fasting conditions. A total of 13 consecutive doses are administered. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. Receives: Drug: NH102; Drug: Placebo |
| NH102 10mg | Experimental | NH102 10mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). The morning doses on D1 and D7 (around 8:00 AM) are to be given under fasting conditions. A total of 13 consecutive doses are administered. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. Receives: Drug: NH102; Drug: Placebo |
| NH102 15mg (6 mg→10 mg→15 mg） | Experimental | NH102 6/10/15 mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). Days 1-2: 6 mg, bid; Days 3-5: 10 mg, bid; Days 6-9: 15 mg, bid (administered only once on Day 9), for a total of 17 consecutive doses. The morning doses on D1 and D9 (around 8:00 AM) are to be given under fasting conditions. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. Receives: Drug: NH102; Drug: Placebo |
| NH102 20mg (10 mg→15 mg→20 mg） | Experimental | NH102 10/15/20 mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). Days 1-2: 10 mg, bid; Days 3-5: 15 mg, bid; Days 6-9: 20 mg, bid (administered only once on Day 9), for a total of 17 consecutive doses. The morning doses on D1 and D9 (around 8:00 AM) are to be given under fasting conditions. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. Receives: Drug: NH102; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in laboratory parameters following treatment administration
The laboratory parameters include hematology, clinical chemistry, coagulation and urinalysis.
Measured: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in vital sign measurements following treatment adminstration
The items of vital sign include blood pressure, heart rate, body temperature and respiratory rate.
Measured: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in physical examination following treatment administration
Measured: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in 12-lead ECG following treatment administration
Measured: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in Columbia-suicide severity rating scale (C-SSRS) score
Measured: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Secondary outcomes (16)
Plasma PK parameters-Maximum plasma concentration (Cmax) after single-dose administration
Measured: From pre-dose to 12 hours (before the second administration on Day 1)
Plasma PK Parameters-Time for maximum plasma concentration (Tmax)
Measured: From pre-dose to 12 hours (before the second administration on Day 1), and from pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve from zero to 24 hours (AUC0-12h)
Measured: From pre-dose to 12 hours (before the second administration on Day 1)
Plasma PK Parameters-Maximum observed drug concentration at steady state (Cmax,ss)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Minimum observed drug concentration at steady state (Cmin,ss)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK-Parameters-Average drug concentration at steady state (Cav,ss)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve from time zero to the last time point with a measurable concentration (AUC0-t)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve from zero to infinity (AUC0-∞)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve over a dosing interval at steady state (AUCss)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Apparent total body clearance at steady state after extravascular administration (CLss/F)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Trough drug concentration (Ctrough)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Degree of Fluctuation (DF)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Terminal elimination rate constant (λz)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Relative bioavailability based on AUC [Ra(AUC)]
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Terminal half-life (t1/2z)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Measured: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start10 Mar 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324408
- Sponsor's protocol ID
- NH102-12
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiply Ascending Dose of NH102 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07324408
- Acronym / sponsor ID
- NH102-12
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 7 Jan 2026 (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.
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of NH102 when administered as multiple oral dose at escalating dose levels in healthy participants.
Detailed description
The drug being tested in this study is called NH102. NH102 is being tested to treat people who have depression. This study will look at the safety, tolerability and PK of NH102 in healthy participants.
The study may enroll up to 30-40 participants. Participants will be randomly assigned within each cohort to receive NH102 or placebo which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need). The study consists of four dose groups: 3 mg (fixed dose), 10 mg (fixed dose), 15 mg (starting at 6 mg, then escalated to 10 mg, and finally to 15 mg), and 20 mg (starting at 10 mg, then escalated to 15 mg, and finally to 20 mg). Each group enrolls 10 subjects, with 8 receiving NH102 and 2 receiving placebo. For the third and fourth dose groups (15 mg and 20 mg) that follow a titration dosing regimen, each includes 2 sentinel subjects (both male). The two sentinel subjects may be dosed simultaneously. Only after both sentinel subjects complete all 17 doses (with a single dose administered on Day 9) and are observed for at least 24 hours, along with preliminary confirmation of safety, may the remaining subjects in the same dose group proceed with dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NH102 3mg | Experimental | Drug: NH102, Drug: PlaceboNH102 3mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). The morning doses on D1 and D7 (around 8:00 AM) are to be given under fasting conditions. A total of 13 consecutive doses are administered. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. |
| NH102 10mg | Experimental | Drug: NH102, Drug: PlaceboNH102 10mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). The morning doses on D1 and D7 (around 8:00 AM) are to be given under fasting conditions. A total of 13 consecutive doses are administered. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. |
| NH102 15mg (6 mg→10 mg→15 mg） | Experimental | Drug: NH102, Drug: PlaceboNH102 6/10/15 mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). Days 1-2: 6 mg, bid; Days 3-5: 10 mg, bid; Days 6-9: 15 mg, bid (administered only once on Day 9), for a total of 17 consecutive doses. The morning doses on D1 and D9 (around 8:00 AM) are to be given under fasting conditions. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. |
| NH102 20mg (10 mg→15 mg→20 mg） | Experimental | Drug: NH102, Drug: PlaceboNH102 10/15/20 mg or NH102 placebo-matching, tablet, orally, bid (at approximately 8:00 AM and 8:00 PM). Days 1-2: 10 mg, bid; Days 3-5: 15 mg, bid; Days 6-9: 20 mg, bid (administered only once on Day 9), for a total of 17 consecutive doses. The morning doses on D1 and D9 (around 8:00 AM) are to be given under fasting conditions. For fasting doses: fast for at least 10 hours before dosing, fast for 4 hours after dosing, and no water intake 1 hour before and 1 hour after dosing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects aged between 18 and 45 (both inclusive) years old when signing the informed consent.
- Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18.5 and ≤28 kg/m2 at screening.
- Subjects voluntarily participate and sign the informed consent after understanding the purpose, content, procedures and possible risks of the trial.
- The subjects will be able to communicate well with the investigators, be willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the study.
Key exclusion criteria (19 listed)
- The investigator determined that the subjects' present medical history and past medical history had any disease or dysfunction that would affect the clinical trial, including but not limited to diseases of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematological system, etc.
- There is any surgical condition or disease that may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may harm to the subjects participating in the trial; such as history of gastrointestinal operations (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, digestive tract ulcers, history of gastrointestinal bleeding, etc.
- Subjects with past history of allergy to drugs or allergic disease.
- Subjects with currently or past history of mental disorders and brain functional disorders.
- According to the Columbia suicide severity scale (C-SSRS), subjects were at risk of suicide or were at risk of suicide based on the clinical judgment of the researchers, or with past history of self-injurious behavior.
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 |
|---|---|---|
| NH102tables orally | Drug | NH102 10mg, NH102 15mg (6 mg→10 mg→15 mg）, NH102 20mg (10 mg→15 mg→20 mg）, NH102 3mg |
| Placebotables orally | Drug | NH102 10mg, NH102 15mg (6 mg→10 mg→15 mg）, NH102 20mg (10 mg→15 mg→20 mg）, NH102 3mg |
Primary outcome
Number of participants with adverse events
Time frame: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in laboratory parameters following treatment administration
Time frame: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
The laboratory parameters include hematology, clinical chemistry, coagulation and urinalysis.
Number of participants with change in vital sign measurements following treatment adminstration
Time frame: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
The items of vital sign include blood pressure, heart rate, body temperature and respiratory rate.
Number of participants with change in physical examination following treatment administration
Time frame: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in 12-lead ECG following treatment administration
Time frame: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
Number of participants with change in Columbia-suicide severity rating scale (C-SSRS) score
Time frame: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)
16 secondary outcomes
Plasma PK parameters-Maximum plasma concentration (Cmax) after single-dose administration
Time frame: From pre-dose to 12 hours (before the second administration on Day 1)
Plasma PK Parameters-Time for maximum plasma concentration (Tmax)
Time frame: From pre-dose to 12 hours (before the second administration on Day 1), and from pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve from zero to 24 hours (AUC0-12h)
Time frame: From pre-dose to 12 hours (before the second administration on Day 1)
Plasma PK Parameters-Maximum observed drug concentration at steady state (Cmax,ss)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Minimum observed drug concentration at steady state (Cmin,ss)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK-Parameters-Average drug concentration at steady state (Cav,ss)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve from time zero to the last time point with a measurable concentration (AUC0-t)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve from zero to infinity (AUC0-∞)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Area Under Curve over a dosing interval at steady state (AUCss)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Apparent total body clearance at steady state after extravascular administration (CLss/F)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Trough drug concentration (Ctrough)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Degree of Fluctuation (DF)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Terminal elimination rate constant (λz)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Relative bioavailability based on AUC [Ra(AUC)]
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Terminal half-life (t1/2z)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
Plasma PK Parameters-Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: From pre-dose on Day 7 to 48 hours (Day 9) for the 3 mg and 10 mg dose groups, or from pre-dose on Day 9 to 24 hours (Day 10) for the 15 mg and 20 mg dose groups.
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 7 Jan 2026.
- 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 NH102 in people with Depression, run by Jiangsu Nhwa 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 4 inclusion and 19 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 7 Jan 2026. 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. 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?
Number of participants with adverse events (time frame: Baseline up to Day 9 ( the 3 mg and 10mg dose groups) or Day 10 (the 15 mg and 20 mg dose groups)). 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 7 Jan 2026.