DepressionPhase 1NCT05015192
Single 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 single 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
- 55 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2021to 11 Jan 2022
- 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.
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- 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.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Single 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 single 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 72 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). Each cohort will enroll 12 participants，which including 2 sentries (all were male, one receive NH102 and the other receive placebo) and 10 subjects(4 males and 4 females receive NH102 and 1 male and 1 female receive placebo). Participants enrolled in Cohort 1 to 6 will receive NH102 3mg, 9mg, 20mg, 40mg, 60mg and 80 mg or NH102 placebo-matching tablet. 2 sentries in all cohorts can be administered at the same time, and the remaining subjects of the same cohort can be administered only after observation for at least 24 hours and initial safety confirmation.
- 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
Also called H04
tablets, orally
PlaceboDrug
tablets, orally
| Study group | Role | What they receive |
|---|---|---|
| NH102 3mg | Experimental | NH102 3mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. Receives: Drug: NH102; Drug: Placebo |
| NH102 9mg | Experimental | NH102 9mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. Receives: Drug: NH102; Drug: Placebo |
| NH102 20mg | Experimental | NH102 20mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. Receives: Drug: NH102; Drug: Placebo |
| NH102 40mg | Experimental | NH102 40mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. Receives: Drug: NH102; Drug: Placebo |
| NH102 60mg | Experimental | NH102 60mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. Receives: Drug: NH102; Drug: Placebo |
| NH102 80mg | Experimental | NH102 80mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. 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 as a measure of safety and tolerability
To investigate the safety and tolerability of NH102 by assessment of AEs following administration in SAD
Measured: Baseline up to Day 11
Secondary outcomes (6)
PK parameters - Cmax
Maximum Observed Plasma Concentration of NH102
Measured: up to 72 hours
PK parameters - Tmax
Time to Reach the Maximum Plasma Concentration (Cmax) of NH102
Measured: up to 72 hours
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Measured: up to 72 hours
PK parameters - t½
apparent terminal elimination half-life
Measured: up to 72 hours
PK parameters - Vz/F
apparent volume of distribution
Measured: up to 72 hours
PK parameters - CL/F
the Apparent Clearance
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start12 Aug 2021
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huafang Li, MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015192
- Sponsor's protocol ID
- NH102-11
- Status last verified
- Feb 2025
- First submitted
- 19 Aug 2021
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. 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 Single Ascending Dose of NH102 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05015192
- Acronym / sponsor ID
- NH102-11
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 20 Aug 2021 (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 single 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 72 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). Each cohort will enroll 12 participants，which including 2 sentries (all were male, one receive NH102 and the other receive placebo) and 10 subjects(4 males and 4 females receive NH102 and 1 male and 1 female receive placebo). Participants enrolled in Cohort 1 to 6 will receive NH102 3mg, 9mg, 20mg, 40mg, 60mg and 80 mg or NH102 placebo-matching tablet. 2 sentries in all cohorts can be administered at the same time, and the remaining subjects of the same cohort can be administered only after observation for at least 24 hours and initial safety confirmation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NH102 3mg | Experimental | Drug: NH102, Drug: PlaceboNH102 3mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| NH102 9mg | Experimental | Drug: NH102, Drug: PlaceboNH102 9mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| NH102 20mg | Experimental | Drug: NH102, Drug: PlaceboNH102 20mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| NH102 40mg | Experimental | Drug: NH102, Drug: PlaceboNH102 40mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| NH102 60mg | Experimental | Drug: NH102, Drug: PlaceboNH102 60mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| NH102 80mg | Experimental | Drug: NH102, Drug: PlaceboNH102 80mg, tablet, orally, once on Day 1 or NH102 placebo-matching tablet, orally, once on Day 1. NH102 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
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 |
|---|---|---|
| NH102Also: H04tablets, orally | Drug | NH102 20mg, NH102 3mg, NH102 40mg, NH102 60mg, NH102 80mg, NH102 9mg |
| Placebotablets, orally | Drug | NH102 20mg, NH102 3mg, NH102 40mg, NH102 60mg, NH102 80mg, NH102 9mg |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Baseline up to Day 11
To investigate the safety and tolerability of NH102 by assessment of AEs following administration in SAD
6 secondary outcomes
PK parameters - Cmax
Time frame: up to 72 hours
PK parameters - Tmax
Time frame: up to 72 hours
PK parameters - AUC0-∞
Time frame: up to 72 hours
PK parameters - t½
Time frame: up to 72 hours
PK parameters - Vz/F
Time frame: up to 72 hours
PK parameters - CL/F
Time frame: up to 72 hours
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 19 Feb 2025.
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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.
Huafang Li, MD principal investigator
Shanghai Mental Health Center
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 19 Feb 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. 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 as a measure of safety and tolerability (time frame: Baseline up to Day 11). 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 19 Feb 2025.