Tolerance, PK and PD Effects Study of TPN-672 in Chinese Healthy Volunteers

NCT03931668 | Unknown Early Phase 1 DMC

• 2 other identifiers: SMHC-180TPN672-KYHY-201801
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.

Conditions

PHA1A

Keywords

tolerance; pharmacokinetics; pharmacodynamics; TPN-672

Outcome Measures

Primary Outcomes (7)

• Adverse events

  Number of Subjects with adverse events during clinical trial

  48 hours

• Cmax

  Maximum Plasma Concentration

  48 hours

• AUC

  Area Under the Curve

  48 hours

• Tmax

  Time to Cmax

  48 hours

• T1/2

  Time of half life

  48 hours

• ACR

  Apparent Clearance Rate

  48 hours

• ADV

  Apparent Distribution Volume

  48 hours

Secondary Outcomes (22)

• prolactin

  48 hours

• temperature

  48 hours

• pulse rate

  48 hours

• respiratory

  48 hours

• blood pressure

  48 hours

Study Arms (7)

0.125mg single dose

EXPERIMENTAL

single dose of TPN-672 0.125mg, 2 subjects

Drug: TPN-672

0.25mg single dose

EXPERIMENTAL

single dose of 0.25mg, 10 subjects (8 for TPN-672, 2 for placebo)

Drug: TPN-672

0.5mg single dose

EXPERIMENTAL

single dose of 0.5mg, 10 subjects (8 for TPN-672, 2 for placebo)

Drug: TPN-672

1mg single dose

EXPERIMENTAL

single dose of 1mg, 10 subjects (8 for TPN-672, 2 for placebo)

Drug: TPN-672

2mg single dose

EXPERIMENTAL

single dose of 2mg, 10 subjects (8 for TPN-672, 2 for placebo)

Drug: TPN-672

3mg single dose

EXPERIMENTAL

single dose of 3mg, 10 subjects (8 for TPN-672, 2 for placebo)

Drug: TPN-672

4mg single dose

EXPERIMENTAL

single dose of 4mg, 10 subjects (8 for TPN-672, 2 for placebo)

Drug: TPN-672

Interventions

TPN-672 DRUG

single dose of TPN-672 maleate tablet

Also known as: TPN-672 maleate tablet

0.125mg single dose; 0.25mg single dose; 0.5mg single dose; 1mg single dose; 2mg single dose; 3mg single dose; 4mg single dose

Eligibility Criteria

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

You may qualify if:

• Body weight \> 50kg(male) or \> 45kg(female), 19 \<BMI\<26 kg/m2.
• Good communication with investigators, willingness and ability to abide by the lifestyle restrictions stipulated in clinical trial
• Women or men within childbearing age do not have a fertility plan within 3 months after the end of the trial, and agree to adopt contraceptive measures approved (such as intrauterine device, condom, sperm killing gel, condom, uterine cap, etc.) throughout the clinical trial period.
• Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, can complete the entire trial process according to the requirements of the trial.

You may not qualify if:

• Investigator determined that there were diseases or functional disorders affecting clinical trials, including, but not limited to, central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system and blood system.
• Mental illness or previous history of mental illness;
• Have a history of ophthalmic diseases, such as abnormal color vision, retinitis pigmentosa, macular degeneration, etc.
• Have a history of malignant tumors or other diseases that are not suitable for clinical trials;
• Any surgical condition or condition that may significantly affect drug absorption, distribution, metabolism and excretion, or that may pose a hazard to the subjects participating in the study, such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.
• Those who are known to have a history of drug allergy, allergic disease or allergic constitution of the tested drug ingredients or similar drugs;
• Smokers who smoked more than 10 cigarettes or the same amount of tobacco per day in the first year of screening;
• Alcohol addiction within 1 year before screening, with an average weekly alcohol intake of more than 14 units (1 unit = 285 ml beer or 25 ml spirits or 150 ml wine) or positive alcohol breath test;
• Those who had a history of drug abuse or drug abuse within 1 year before screening, or those who had positive urinary drug screening;
• Physical examination, current medical history and vital signs were found to be abnormal by researchers and have clinical significance.
• Resting pulse rate \< 55/min or \> 100/min; systolic pressure \< 90 mmHg or \> 140 mmHg, diastolic pressure \< 60 mmHg or \> 90 mmHg;
• lead electrocardiogram (ECG) examination was found to be abnormal by investigator and had clinical significance; or the following ECG abnormalities occurred: PR interval \> 220 ms, QRS complex wave duration \> 120 ms, long QT syndrome (QTc \> 450 ms);
• Family history of sudden cardiac death (less than 40 years old);
• Abnormal blood routine examination and urine routine examination have clinical significance.
• Aspartate transferase (AST), alanine transferase (ALT), creatinine (Cr), urea nitrogen (BUN) exceeded the normal upper limit.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Jiangsu Kanion Pharmaceutical Co.: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Study Officials

• Yifeng SHEN, MD PhD

  Shanghai Mental Health Center

  STUDY DIRECTOR

Central Study Contacts

Yifeng SHEN, MD PhD

CONTACT

86-21-34773657; shenyifeng@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 30, 2019
• Study Start: April 17, 2019
• Primary Completion: October 17, 2020
• Study Completion: December 17, 2020
• Last Updated: December 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)