Single Ascending Dose Study of NH102 in Healthy Subjects

NCT05015192 | Completed Phase 1 DMC

• 1 other identifier: NH102-11
• Study Type: interventional
• Target: 55
• 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 single oral dose at escalating dose levels in healthy participants.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline up to Day 11

Secondary Outcomes (6)

• PK parameters - Cmax

  up to 72 hours

• PK parameters - Tmax

  up to 72 hours

• PK parameters - AUC0-∞

  up to 72 hours

• PK parameters - t½

  up to 72 hours

• PK parameters - Vz/F

  up to 72 hours

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: NH102; Drug: Placebo

Interventions

NH102 DRUG

tablets, orally

Also known as: H04

NH102 20mg; NH102 3mg; NH102 40mg; NH102 60mg; NH102 80mg; NH102 9mg

Placebo DRUG

tablets, orally

NH102 20mg; NH102 3mg; NH102 40mg; NH102 60mg; NH102 80mg; NH102 9mg

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, China

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Huafang Li, MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

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: August 19, 2021
• First Posted: August 20, 2021
• Study Start: August 12, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CN (1)