Parkinson DiseasePhase 1NCT04625361
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects
A Phase 1 study testing HEC122505MsOH in people with Parkinson Disease, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- HEC122505MsOH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2021to 6 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects
- Conditions
- Parkinson Disease
- Being tested
- HEC122505MsOH
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC122505MsOHDrug
Part2：Mulltiple doses once daily, up to 8 days
| Study group | Role | What they receive |
|---|---|---|
| Single dose of HEC122505MsOH Tablets（pilot trial arm） | Experimental | Healthy subjects receive single dose of tablets HEC122505MsOH Receives: Drug: HEC122505MsOH |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 1） | Experimental | Healthy subjects receive single dose of HEC122505MsOH or matching placebo Receives: Drug: HEC122505MsOH |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 2） | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo Receives: 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. Receives: Drug: HEC122505MsOH |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 4） | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo Receives: Drug: HEC122505MsOH |
| Single dose of HEC122505MsOH Tablets（Part 1，Cohort 5） | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo Receives: Drug: HEC122505MsOH |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 6） | Experimental | Healthy subjects receive single dose of HEC122505MsOH tablets or matching placebo Receives: Drug: HEC122505MsOH |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 1） | Experimental | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo Receives: Drug: HEC122505MsOH |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 2） | Experimental | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo Receives: Drug: HEC122505MsOH |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 3） | Experimental | Healthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo Receives: Drug: HEC122505MsOH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Part 1：up to 6 days; Part 2: up to 13 days.
Secondary outcomes (8)
Cmax
Maximum Plasma Concentration(Cmax)
Measured: up to 120 hours
AUC
Area Under the Curve(AUC)
Measured: up to 120 hours
Tmax Tmax
Maximum Peak Time(Tmax)
Measured: up to 120 hours
t½
Elimination Half-life(t½)
Measured: up to 120 hours
MRT
Mean Residence Time(MRT)
Measured: up to 120 hours
CL/F
Apparent Clearance(CL/F)
Measured: up to 120 hours
Vz/F
Apparent Volume of Distribution(Vz/F)
Measured: up to 120 hours
Kel
Elimination Rate Constant(Kel)
Measured: up to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start20 Jan 2021
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625361
- Sponsor's protocol ID
- HEC122505-P-01/CRC-C2017
- Status last verified
- Apr 2023
- First submitted
- 9 Nov 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04625361
- Acronym / sponsor ID
- HEC122505-P-01/CRC-C2017
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Single dose of HEC122505MsOH Tablets（pilot trial arm） | Experimental | Drug: HEC122505MsOHHealthy subjects receive single dose of tablets HEC122505MsOH |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 1） | Experimental | Drug: HEC122505MsOHHealthy subjects receive single dose of HEC122505MsOH or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 2） | Experimental | Drug: HEC122505MsOHHealthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 3,Fed/Fasting） | Experimental | Drug: HEC122505MsOHFollowing 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. |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 4） | Experimental | Drug: HEC122505MsOHHealthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1，Cohort 5） | Experimental | Drug: HEC122505MsOHHealthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Single dose of HEC122505MsOH Tablets（Part 1， Cohort 6） | Experimental | Drug: HEC122505MsOHHealthy subjects receive single dose of HEC122505MsOH tablets or matching placebo |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 1） | Experimental | Drug: HEC122505MsOHHealthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 2） | Experimental | Drug: HEC122505MsOHHealthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
| Multiple doses of HEC122505MsOH Tablets（Part 2， Cohort 3） | Experimental | Drug: HEC122505MsOHHealthy subjects receive multiple doses of HEC122505MsOH tablets or matching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC122505MsOHPart2：Mulltiple doses once daily, up to 8 days | Drug | 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） |
Primary outcome
The Number of Adverse Events (AEs)
Time frame: 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
8 secondary outcomes
Cmax
Time frame: up to 120 hours
AUC
Time frame: up to 120 hours
Tmax Tmax
Time frame: up to 120 hours
t½
Time frame: up to 120 hours
MRT
Time frame: up to 120 hours
CL/F
Time frame: up to 120 hours
Vz/F
Time frame: up to 120 hours
Kel
Time frame: up to 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEC122505MsOH in people with Parkinson Disease, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Adverse Events (AEs) (time frame: Part 1：up to 6 days; Part 2: up to 13 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.