Single Ascending Dose Study of NH102 in Healthy Subjects

Depression Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Single Ascending Dose of NH102 in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05015192
• Other study ID #: NH102-11
• Status: Recruiting
• Phase: Phase 1
• Start date: August 12, 2021
• Est. completion date: April 2022

Study information

• Verified date: August 2021
• Source: Jiangsu Nhwa Pharmaceutical Co., Ltd.
• Contact: Huafang Li, MD
• Phone: 021-34773107
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• NH102
tablets, orally
• Placebo
tablets, orally

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Nhwa Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK parameters - Cmax	Maximum Observed Plasma Concentration of NH102	up to 72 hours
Secondary	PK parameters - Tmax	Time to Reach the Maximum Plasma Concentration (Cmax) of NH102	up to 72 hours
Secondary	PK parameters - AUC0-8	area under the concentration versus time curve (AUC) from time zero to infinity	up to 72 hours
Secondary	PK parameters - t½	apparent terminal elimination half-life	up to 72 hours
Secondary	PK parameters - Vz/F	apparent volume of distribution	up to 72 hours
Secondary	PK parameters - CL/F	the Apparent Clearance	up to 72 hours