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

Sponsor

Sunshine Lake Pharma Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04625361

Collaborator

(none)

102

Enrollment

Location

Arms

9.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: HEC122505MsOH	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single dose of HEC122505MsOH Tablets（pilot trial arm） Healthy subjects receive single dose of tablets HEC122505MsOH	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Single dose of HEC122505MsOH Tablets（Part 1， Cohort 1） Healthy subjects receive single dose of HEC122505MsOH or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Single dose of HEC122505MsOH Tablets（Part 1， Cohort 2） Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Single dose of HEC122505MsOH Tablets（Part 1， Cohort 3,Fed/Fasting） Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Single dose of HEC122505MsOH Tablets（Part 1， Cohort 4） Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Single dose of HEC122505MsOH Tablets（Part 1，Cohort 5） Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Single dose of HEC122505MsOH Tablets（Part 1， Cohort 6） Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 1） Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 2） Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days
Experimental: Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 3） Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo	Drug: HEC122505MsOH Part2：Mulltiple doses once daily, up to 8 days

Outcome Measures

Primary Outcome Measures

The Number of Adverse Events (AEs) [Part 1：up to 6 days; Part 2: up to 13 days.]
To investigate the safety and tolerability of HEC122505MsOH by assessment of AEs (non-serious and serious) following administration of oral HEC122505MsOH tablets

Secondary Outcome Measures

Cmax [up to 120 hours]
Maximum Plasma Concentration(Cmax)
AUC [up to 120 hours]
Area Under the Curve(AUC)
Tmax Tmax [up to 120 hours]
Maximum Peak Time(Tmax)
t½ [up to 120 hours]
Elimination Half-life(t½)
MRT [up to 120 hours]
Mean Residence Time(MRT)
CL/F [up to 120 hours]
Apparent Clearance(CL/F)
Vz/F [up to 120 hours]
Apparent Volume of Distribution(Vz/F)
Kel [up to 120 hours]
Elimination Rate Constant(Kel)

Other Outcome Measures

MAO-B [up to 120 hours]
Monoamine Oxidase B（MAO-B）
MAO-A [up to 120 hours]
Monoamine Oxidase A（MAO-A）

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects who are willing and are able to provide a written informed consent to participate in the study.
Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
Subjects aged between 18 and 45 (both inclusive) years old.
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.
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:

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.
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.
nown allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.
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.
Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
Positive results from urine drug screen test.
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.
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.
Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
Subjects who plan to receive or have had organ transplants.
Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
Subjects who participated in another clinical trial within 3 months prior to initial dosing.
Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Xuhui Central Hospital	Shanghai		China

Sponsors and Collaborators

Sunshine Lake Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunshine Lake Pharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04625361

Other Study ID Numbers:

HEC122505-P-01/CRC-C2017

First Posted:

Nov 12, 2020

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of May 10, 2021