Parkinson DiseasePhase 1NCT04164121

A Clinical Study Trial of Phenlarmide in China

A Phase 1 study testing Phenlarmide Tablets in people with Parkinson Disease, run by Yiling Pharmaceutical Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers. 2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers. 3. Provide basis for dosage setting for follow-up clinical research. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
What is being tested?: Phenlarmide Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteChina
Study dates: 17 Dec 2019to 2 Dec 2020
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1)18-65 years old (including upper and lower limits);
2)Men and women are not limited;
3)Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits);
4)Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.

Who cannot join

1)There is a history of heart, liver, kidney, respiratory, digestive tract, nervous system, endocrine, immune or hematological diseases judged by researchers as having clinical significance;
2)There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers;
3)Any drug was taken within two weeks before the study was administered, and the researchers believe that this condition may affect the evaluation results of the study;
4)There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant;
5)The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening;
6)One year before the study was administered, some researchers believed that alcohol or drug abuse history might affect the results of this study, or that alcohol breath test or urine drug screening test were positive during screening;

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7)Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage;
8)Those who participated in any clinical trial within 3 months before administration;
9)Those who donated blood more than 400 mL or 2 units within 3 months before administration;
10)Do not agree to avoid the use of tobacco, alcohol or caffeine-containing beverages within 24 hours before and during the trial, or to avoid vigorous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism and excretion;
11)Pregnant or lactating women, or those with positive serum HCG test before administration, or those who are unable or unwilling to adopt contraceptive measures approved by the researchers during the study period and within three months after the end of the study, as directed by the researchers;
12)Researchers do not consider it suitable for participants in this clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking union medical college hospital
Beijing, Beijing Municipality, 100032

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers

To evaluate the tolerance and safety of FLA tablets in healthy volunteers.
To evaluate the pharmacokinetics of FLA tablets in healthy volunteers.
Provide basis for dosage setting for follow-up clinical research.

Conditions: Parkinson Disease
Being tested: Phenlarmide Tablets, Placebos
Keywords: Tolerance, Safety, Pharmacokinetic characteristics
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phenlarmide TabletsDrug
Also called FLZ
Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.
PlacebosDrug
Also called FLZ-Placebos
Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.

Study groups in NCT04164121
Study group	Role	What they receive
FLZ-150mg experimental	Experimental	Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. Receives: Drug: Phenlarmide Tablets
FLZ-150mg placebo	Placebo comparator	Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. Receives: Drug: Placebos
FLZ-600mg experimental	Experimental	Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. Receives: Drug: Phenlarmide Tablets
FLZ-600mg placebo	Placebo comparator	Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. Receives: Drug: Placebos
FLZ-900mg experimental	Experimental	Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17. Receives: Drug: Phenlarmide Tablets
FLZ-900mg placebo	Placebo comparator	Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17. Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerance evaluation index
maximum tolerated dose (MTD), dose limited toxicity (DLT)
Measured: From 0 to 20 days after dosing
Tmax
The amount of time that a drug is present at the maximum concentration in serum.
Measured: From 0 to 168 hours after the first dose
Peak Plasma Concentration (Cmax)
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
t1/2
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
Vz/F
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
CL/F
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
Mean residence time (MRT) parameter
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
Kel
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
Area under the plasma concentration versus time curve (AUC0-∞)
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
AUC0-24
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
AUC0-72
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
AUC0-last
The PK parameters of the plasma sample
Measured: From 0 to 168 hours after the first dose
Tmax, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
Cmax, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
Cmin, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
Cavg, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
t1/2, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
AUC0-24, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
AUC0-72, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
AUC0-∞, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose
AUC0-last, ss
The PK parameters of the plasma sample
Measured: From 0 to 72 hours after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 20192 Dec 2020

First posted15 Nov 2019
Study start17 Dec 2019
Primary completion2 Dec 2020
Study completion2 Dec 2020

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.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04164121
Sponsor's protocol ID: FLZPD1002
Status last verified: Dec 2021
First submitted: 12 Nov 2019
Last updated: 14 Dec 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT04164121
Acronym / sponsor ID: FLZPD1002
Conditions: Parkinson Disease
Keywords: Tolerance, Safety, Pharmacokinetic characteristics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Yiling Pharmaceutical Inc.Industry (pharma, biotech, devices)
Study start: 17 Dec 2019 (actual)
Primary completion: 2 Dec 2020 (actual)
Study completion: 2 Dec 2020 (actual)
First posted: 15 Nov 2019 (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.

To evaluate the tolerance and safety of FLA tablets in healthy volunteers.
To evaluate the pharmacokinetics of FLA tablets in healthy volunteers.
Provide basis for dosage setting for follow-up clinical research.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
FLZ-150mg experimental	Experimental	Drug: Phenlarmide TabletsOral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17.
FLZ-150mg placebo	Placebo comparator	Drug: PlacebosOral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17.
FLZ-600mg experimental	Experimental	Drug: Phenlarmide TabletsOral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17.
FLZ-600mg placebo	Placebo comparator	Drug: PlacebosOral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17.
FLZ-900mg experimental	Experimental	Drug: Phenlarmide TabletsOral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17.
FLZ-900mg placebo	Placebo comparator	Drug: PlacebosOral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

1)18-65 years old (including upper and lower limits);
2)Men and women are not limited;
3)Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits);
4)Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.

Key exclusion criteria (12 listed)

1)There is a history of heart, liver, kidney, respiratory, digestive tract, nervous system, endocrine, immune or hematological diseases judged by researchers as having clinical significance;
2)There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers;
3)Any drug was taken within two weeks before the study was administered, and the researchers believe that this condition may affect the evaluation results of the study;
4)There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant;
5)The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening;

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
Phenlarmide TabletsAlso: FLZOral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.	Drug	FLZ-150mg experimental, FLZ-600mg experimental, FLZ-900mg experimental
PlacebosAlso: FLZ-PlacebosOral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.	Drug	FLZ-150mg placebo, FLZ-600mg placebo, FLZ-900mg placebo

Primary outcome

Tolerance evaluation index
Time frame: From 0 to 20 days after dosing
maximum tolerated dose (MTD), dose limited toxicity (DLT)
Tmax
Time frame: From 0 to 168 hours after the first dose
The amount of time that a drug is present at the maximum concentration in serum.
Peak Plasma Concentration (Cmax)
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
t1/2
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
Vz/F
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
CL/F
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
Mean residence time (MRT) parameter
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
Kel
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
AUC0-24
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
AUC0-72
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
AUC0-last
Time frame: From 0 to 168 hours after the first dose
The PK parameters of the plasma sample
Tmax, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
Cmax, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
Cmin, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
Cavg, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
t1/2, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
AUC0-24, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
AUC0-72, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
AUC0-∞, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample
AUC0-last, ss
Time frame: From 0 to 72 hours after the last dose
The PK parameters of the plasma sample

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 14 Dec 2021.

Related trials for Parkinson Disease

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Enrolling by invitationObservational study
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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 Phenlarmide Tablets in people with Parkinson Disease, run by Yiling Pharmaceutical Inc. 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 4 inclusion and 12 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 14 Dec 2021. 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. Some participants in this study may receive a placebo. 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?

Tolerance evaluation index (time frame: From 0 to 20 days after dosing). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04164121.

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 14 Dec 2021.