Multiple Ascending Dose Study of NH102 in Healthy Subjects

NCT07324408 | Completed Phase 1 DMC

• 1 other identifier: NH102-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events

  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.

  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.

  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

  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

  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

  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

  From pre-dose to 12 hours (before the second administration on Day 1)

• Plasma PK Parameters-Time for maximum plasma concentration (Tmax)

  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)

  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)

  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)

  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.

Study Arms (4)

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.

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.

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.

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.

Drug: NH102; Drug: Placebo

Interventions

NH102 DRUG

tables orally

NH102 10mg; NH102 15mg (6 mg→10 mg→15 mg）; NH102 20mg (10 mg→15 mg→20 mg）; NH102 3mg

Placebo DRUG

tables orally

NH102 10mg; NH102 15mg (6 mg→10 mg→15 mg）; NH102 20mg (10 mg→15 mg→20 mg）; NH102 3mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Nhwa Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 201108, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

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: December 10, 2025
• First Posted: January 7, 2026
• Study Start: March 10, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)