A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects

Design：Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives：

1. To investigate the tolerability and safety of Chinese healthy adult subjects after a single oral administration of Finamine tablets;
2. To investigate the pharmacokinetic (PK) characteristics of Finamine tablets;
3. To provide dose setting basis for follow-up clinical studies. Investigational subject:Healthy-adult subjects in China

34 cases (including 4 cases of the pre- trial), of which the 150mg dose group is in the 4 cases of pre- trial (open, all accepted Finamine tablets orally, among whom, two receive it under fasting condition , and the other two receive it half an hour post a high-fat meal started). There are 6 cases in the formal trial (the subjects' ratio of investigational drug to placebo is 2:1). In all other dose groups, the subjects' ratio of investigational drug to placebo is 3:1.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Finamine tablets; Drug: Placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050035
      • Shijiazhuang Yiling Pharmaceutical Co. Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: 18 to 65 years old (including the upper and lower limits).
2. Male or female
3. Weight ≥50kg, BMI 18-28 kg/m2 (including the upper and lower limits).
4. Understand and sign the informed consent form，able to understand the process and requirements of the study, and volunteer to participate in this study.

Exclusion Criteria:

If being one of the following conditions, subjects cannot be selected

1. There is a history of disease in heart, liver, kidney, respiratory system, digestive tract, nervous system, endocrine system, immune system, blood system, etc., that the investigator has determined to be clinically significant;
2. Abnormalities are in vital signs, comprehensive physical examinations, laboratory tests, ECG examinations, etc., and they are considered clinically significant by the investigator;
3. Any drug was taken within two weeks prior to dosing in the study , and the investigators believe that this condition may affect the assessment results of this study;
4. There is an seriously allergic history of food and drug or hypersensitivity that the investigator has identified as clinically significant;
5. There are positive results of serological tests (HBsAg, anti-HCV, anti-HIV, or TP-Ab) during screening;
6. Within 1 years prior to the administration of the drug, the history of drinking or drug abuse, that the investigator believes it may affect the evaluation results of the study. Or, during screening, the alcohol breath test or the urine screening test is positive.
7. Subjects cannot quit smoking or quit drinking during the study period or subjects' carbon monoxide breath test is ≥7ppm during the screening period (when the investigator thinks it necessary, it can be further confirmed by urine cotinine test);
8. Subjects participated in any drug clinical trial within 3 months prior to study dosing;
9. Subjects donated blood ≥400mL or 2 units within 3 months prior to study dosing;
10. Subjects do not agree to avoid the use of tobacco ,alcoholic beverages or caffeinated beverages, or to avoid strenuous exercise and other factors that influence such as absorption, distribution, metabolism, and excretion of drugs during 24 hours before dosing in the trial and in the duration of the trial;
11. Pregnant or breastfeeding women, or subjects who are tested positive for serum HCG before dosing in the trial, or who are unable or unwilling to take contraception approved by researchers during the study period as directed by the investigator;
12. Subjects who, in the opinion of nvestigators, are not suitable for participating in this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pre-trial, fasting administration; 2 cases were given 150mg Finamine tablets（pre-trial，fasting administration）	Drug: Finamine tablets; taken Finamine tablets orally; Other Names: Finamine tablet
Experimental: pre-trial,after high fat meal; 2 cases were given 150mg Finamine tablets (pre- trial，after high fat meal)	Drug: Finamine tablets; taken Finamine tablets orally; Other Names: Finamine tablet
Placebo Comparator: formal trial-150mg; 4 cases were given 150mg Finamine tablets 2 cases were given placebo	Drug: Finamine tablets; taken Finamine tablets orally; Other Names: Finamine tablet; Drug: Placebo tablets; taken Placebo tablets orally
Placebo Comparator: formal trial-300mg; 6 cases were given 300mg Finamine tablets 2 cases were given placebo	Drug: Finamine tablets; taken Finamine tablets orally; Other Names: Finamine tablet; Drug: Placebo tablets; taken Placebo tablets orally
Placebo Comparator: formal trial-600mg; 6 cases were given 600mg Finamine tablets 2 cases were given placebo	Drug: Finamine tablets; taken Finamine tablets orally; Other Names: Finamine tablet; Drug: Placebo tablets; taken Placebo tablets orally
Placebo Comparator: formal trial-1200mg; 6 cases were given 1200mg Finamine tablets 2 cases were given placebo	Drug: Finamine tablets; taken Finamine tablets orally; Other Names: Finamine tablet; Drug: Placebo tablets; taken Placebo tablets orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance evaluation	maximum tolerated dose（MTD）、dose-limiting toxicity（DLT）	From 0 to 96 hours after dosing
AE	The occurrence rate of AE.	From 0 to 96 hours after dosing
AUC0-96h	area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing.	From 0 to 96 hours after dosing
AUCinf	area under the concentration-time curve from the time of dosing extrapolated to time infinity.	From 0 to 96 hours after dosing
Peak Plasma Concentration (Cmax)	The PK parameters of the plasma sample.	From 0 to 96 hours after dosing
Tmax	The amount of time that a drug is present at the maximum concentration in serum.	From 0 to 96 hours after dosing
t1/2	The PK parameters of the plasma sample.	From 0 to 96 hours after dosing

Collaborators and Investigators

• Sponsor: Yiling Pharmaceutical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): April 27, 2018
• Study Completion (Actual): April 27, 2018

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: YLCDP-2015-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No