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

NCT04625361 | Completed Phase 1

• 1 other identifier: HEC122505-P-01/CRC-C2017
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Cmax

  up to 120 hours

• AUC

  up to 120 hours

• Tmax Tmax

  up to 120 hours

• t½

  up to 120 hours

• MRT

  up to 120 hours

Other Outcomes (2)

• MAO-B

  up to 120 hours

• MAO-A

  up to 120 hours

Study Arms (10)

Single dose of HEC122505MsOH Tablets（pilot trial arm）

EXPERIMENTAL

Healthy subjects receive single dose of tablets HEC122505MsOH

Drug: HEC122505MsOH

Single dose of HEC122505MsOH Tablets（Part 1， Cohort 1）

EXPERIMENTAL

Healthy subjects receive single dose of HEC122505MsOH or matching placebo

Drug: HEC122505MsOH

Single dose of HEC122505MsOH Tablets（Part 1， Cohort 2）

EXPERIMENTAL

Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo

Drug: HEC122505MsOH

Single dose of HEC122505MsOH Tablets（Part 1， Cohort 3,Fed/Fasting）

EXPERIMENTAL

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

Single dose of HEC122505MsOH Tablets（Part 1， Cohort 4）

EXPERIMENTAL

Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo

Drug: HEC122505MsOH

Single dose of HEC122505MsOH Tablets（Part 1，Cohort 5）

EXPERIMENTAL

Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo

Drug: HEC122505MsOH

Single dose of HEC122505MsOH Tablets（Part 1， Cohort 6）

EXPERIMENTAL

Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo

Drug: HEC122505MsOH

Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 1）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo

Drug: HEC122505MsOH

Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 2）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo

Drug: HEC122505MsOH

Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 3）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo

Drug: HEC122505MsOH

Interventions

HEC122505MsOH DRUG

Part2：Mulltiple doses once daily, up to 8 days

Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 1）; Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 2）; Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 3）; Single dose of HEC122505MsOH Tablets（Part 1， Cohort 1）; Single dose of HEC122505MsOH Tablets（Part 1， Cohort 2）; Single dose of HEC122505MsOH Tablets（Part 1， Cohort 3,Fed/Fasting）; Single dose of HEC122505MsOH Tablets（Part 1， Cohort 4）; Single dose of HEC122505MsOH Tablets（Part 1， Cohort 6）; Single dose of HEC122505MsOH Tablets（Part 1，Cohort 5）; Single dose of HEC122505MsOH Tablets（pilot trial arm）

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 12, 2020
• Study Start: January 20, 2021
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)