New depression drug NH102 begins human safety testing
NCT ID NCT07324408
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested the safety and tolerability of a new drug called NH102 in 40 healthy adults. Participants received either the drug or a placebo to check for side effects and how the drug moves through the body. The study is complete, but it does not yet test if NH102 works for depression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NH102 (oral tablet)
- What this could lead to
- If successful, this could lead to a new treatment option for depression.
- What could go wrong
- This is a very early Phase 1 trial in healthy volunteers, not people with depression. It only tests safety and dosing, not whether the drug works for depression. Many drugs fail at this stage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
40 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
-
Apr 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects aged between 18 and 45 (both inclusive) years old when signing the informed consent. 2. 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. 3. Subjects voluntarily participate and sign the informed consent after understanding the purpose, content, procedures and possible risks of the trial. 4. 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. Exclusion Criteria: 1. 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. 2. 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. 3. Subjects with past history of allergy to drugs or allergic disease. 4. Subjects with currently or past history of mental disorders and brain functional disorders. 5. 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. 6. Subjects have history of drug abuse or positive urine drug tests at screening within 1 year prior. 7. 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. 8. Average amount of daily smoking\>5 cigarettes at screening 3 months prior. 9. Those who have special requirements for food, cannot follow a uniform diet or have difficulty swallowing. 10. 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. 11. 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 ). 12. Subjects who resting heart rate \<55 beats/min or \>100 beats/min; systolic blood pressure \<90mmHg or \>140mmHg; diastolic blood pressure \<60mmHg or \>90mmHg. 13. 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. 14. Subjects who participated in any clinical trial within 3 months before medication. 15. 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. 16. 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. 17. Subjects who had taken any drugs, including prescription and over-the-counter drugs within 2 weeks prior to enrollment. 18. Subjects who directly related to this clinical trial. 19. Subjects have poor compliance or other problems that the researchers believe that it is not suitable for participating.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Depression are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 201108, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Can a Text-Message program help trauma survivors avoid PTSD and depression?
- Can a website help young people understand depression?
- Can a brain scan and your phone predict where depression goes next?
- Can a tailored therapy ease anxiety and depression in autistic teens?
- Reading the Brain's signals to predict who benefits from deep brain stimulation