Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects

Parkinson Disease Clinical Trial

Official title:

A Single Center, Randomized, Double-Blind, Placebo-Controlled Study of Single/Multiple Ascending Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Single Center, Randomized, Double-Blind, Two Periods, Crossover, Food Effect Study of HEC122505MsOH Tablets in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625361
• Other study ID #: HEC122505-P-01/CRC-C2017
• Status: Completed
• Phase: Phase 1
• Start date: January 20, 2021
• Est. completion date: January 6, 2022

Study information

• Verified date: April 2023
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 6, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.

2. Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.

3. Subjects aged between 18 and 45 (both inclusive) years old.

4. Healthy volunteers has a body weight =50 kg (for male) or = 45kg (for female) and body mass index =18 and =28 kg/m2 at screening.

5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.

2. Patients with the following diseases of clinical significance, including but not limited to those with gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases.

3. nown allergic reactions or hypersensitivity to any excipient of the drug formulation(s), anaphylaxis physique.

4. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,Use of any drugs that inhibit or induce liver metabolism within 28 days before the first dose, or use of any of the following drugs within 28 days before the first dose: monoamine oxidase inhibitors, opioids, serotonergic drugs, sympathetic nerves Drugs, breast cancer resistance protein substrates, dopaminergic antagonists, etc.

5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.

6. Positive results from urine drug screen test.

7. History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.

8. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study.

9. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.

10. Subjects who plan to receive or have had organ transplants.

11. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.

12. Subjects who participated in another clinical trial within 3 months prior to initial dosing.

13. Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• HEC122505MsOH
Part2:Mulltiple doses once daily, up to 8 days

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MAO-B	Monoamine Oxidase B(MAO-B)	up to 120 hours
Other	MAO-A	Monoamine Oxidase A(MAO-A)	up to 120 hours
Primary	The Number of Adverse Events (AEs)	To investigate the safety and tolerability of HEC122505MsOH by assessment of AEs (non-serious and serious) following administration of oral HEC122505MsOH tablets	Part 1:up to 6 days; Part 2: up to 13 days.
Secondary	Cmax	Maximum Plasma Concentration(Cmax)	up to 120 hours
Secondary	AUC	Area Under the Curve(AUC)	up to 120 hours
Secondary	Tmax Tmax	Maximum Peak Time(Tmax)	up to 120 hours
Secondary	t½	Elimination Half-life(t½)	up to 120 hours
Secondary	MRT	Mean Residence Time(MRT)	up to 120 hours
Secondary	CL/F	Apparent Clearance(CL/F)	up to 120 hours
Secondary	Vz/F	Apparent Volume of Distribution(Vz/F)	up to 120 hours
Secondary	Kel	Elimination Rate Constant(Kel)	up to 120 hours