Healthy SubjectsPhase 1NCT06137911

Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.

A Phase 1 study testing JYP0061 in people with Healthy Subjects, run by Guangzhou JOYO Pharma Co., Ltd 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: JYP0061
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 94 participants
Where: 1 siteChina
Study dates: 26 Sep 2021to 9 Nov 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-45 years old (including both endpoints), healthy males or females;
Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28kg/m^2 (including both endpoints);
No significant abnormal clinical symptoms, normal physical examination, vital signs, 12-lead electrocardiogram (ECG), chest CT, ultrasound, and laboratory examination important indicators do not show clinically significant abnormalities;
The participants (including partners) have no plans for childbearing from screening to 90 days after the last administration of the study drug, and are willing to take appropriate effective contraceptive measures (non-oral contraceptives);
Fully understanding the study, voluntarily participate in the trial, and willingly sign the written informed consent.

Who cannot join

Pregnant or lactating women;
Individuals with special dietary requirements that cannot comply with a uniform diet;
Suspected or confirmed allergy to any ingredients similar to the study drug or any ingredient in the study drug, or individuals with a history of allergic reactions;
Past or current severe illness/abnormality (including but not limited to cardiac/cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, malignant tumors, hematological, immune, rheumatological, neurological or psychiatric diseases), or any acute or chronic disease or physiological condition that could interfere with the trial results;
Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody; Participated in a clinical trial within the past 3 months;

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200020

Other trials in China

About this study

Official title: Safety, Tolerability and Pharmacokinetic Characteristics of JYP0061 in Healthy Adult Subjects After Single and Multiple Doses: a Single-center, Randomized, Double-blind, Placebo-controlled, Phase I Trial

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of JYP0061 in healthy adult subjects. The main questions it aims to answer are: safety and tolerability of JYP0061 in healthy subjects, the pharmacokinetic characteristics after single and multiple doses and the effect of food on the pharmacokinetic characteristics. Participants will be treated with JYP0061 orally and safety and pharmacokinetic evaluations will be conducted according to the protocol.

Read the detailed description

This study will be an double-blinded, single-center phase I clinical trial. After being informed about the study and potential risks, all subjects giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. And then subjects will be administered for single-dose treatment or 10-day multiple-dose treatment and 5-day safety follow up after the last dose of treatment. The safety and pharmacokinetic measures will be conducted according to the protocol.

Conditions: Healthy Subjects
Being tested: JYP0061, placebo

What participants receive

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

JYP0061Drug
JYP0061 orally administered
placeboDrug
Placebo orally administered

Study groups in NCT06137911
Study group	Role	What they receive
Group A:JYP0061 15mg	Experimental	Experimental: JYP0061 Single ascending dose Receives: Drug: JYP0061
Group B:JYP0061 placebo comparator 15mg	Placebo comparator	Placebo comparator: JYP0061 placebo comparator Single ascending dose Receives: Drug: placebo
Group C:JYP0061 food influence group 15mg	Experimental	Food influence group Receives: Drug: JYP0061
Group D:JYP0061 multiple ascending doses 30mg	Experimental	Multiple ascending doses Receives: Drug: JYP0061
Group E:JYP0061 placebo comparator food influence group 30mg	Placebo comparator	Food influence group Receives: Drug: placebo
Group F:JYP0061 placebo comparator multiple ascending doses 30mg	Placebo comparator	Multiple ascending doses Receives: Drug: placebo

What is being measured

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

The peak plasma concentration that JYP0061 achieves after dosing.
Evaluate patients' electrocardiogram data to detect whether the treatment causes maximum observed concentration of drug substance in plasma
Measured: up to 4 weeks

Secondary outcomes (1)

The time to reach the maximum concentration of JYP0061 in the bloodstream after administration.
Time when the maximum concentration is achieved
Measured: up to 4 weeks

Timeline

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

26 Sep 20219 Nov 2022

First posted18 Nov 2023
Study start26 Sep 2021
Primary completion9 Nov 2022
Study completion9 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06137911
Sponsor's protocol ID: JYP0061M101
Status last verified: Apr 2023
First submitted: 4 Nov 2023
Last updated: 1 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia

All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability and Pharmacokinetic Characteristics of JYP0061 in Healthy Adult Subjects After Single and Multiple Doses: a Single-center, Randomized, Double-blind, Placebo-controlled, Phase I Trial
ClinicalTrials.gov ID: NCT06137911
Acronym / sponsor ID: JYP0061M101
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Guangzhou JOYO Pharma Co., LtdIndustry (pharma, biotech, devices)
Study start: 26 Sep 2021 (actual)
Primary completion: 9 Nov 2022 (actual)
Study completion: 9 Nov 2022 (actual)
First posted: 18 Nov 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Group A:JYP0061 15mg	Experimental	Drug: JYP0061Experimental: JYP0061 Single ascending dose
Group B:JYP0061 placebo comparator 15mg	Placebo comparator	Drug: placeboPlacebo comparator: JYP0061 placebo comparator Single ascending dose
Group C:JYP0061 food influence group 15mg	Experimental	Drug: JYP0061Food influence group
Group D:JYP0061 multiple ascending doses 30mg	Experimental	Drug: JYP0061Multiple ascending doses
Group E:JYP0061 placebo comparator food influence group 30mg	Placebo comparator	Drug: placeboFood influence group
Group F:JYP0061 placebo comparator multiple ascending doses 30mg	Placebo comparator	Drug: placeboMultiple ascending doses

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age 18-45 years old (including both endpoints), healthy males or females;
Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28kg/m^2 (including both endpoints);
No significant abnormal clinical symptoms, normal physical examination, vital signs, 12-lead electrocardiogram (ECG), chest CT, ultrasound, and laboratory examination important indicators do not show clinically significant abnormalities;
The participants (including partners) have no plans for childbearing from screening to 90 days after the last administration of the study drug, and are willing to take appropriate effective contraceptive measures (non-oral contraceptives);
Fully understanding the study, voluntarily participate in the trial, and willingly sign the written informed consent.

Key exclusion criteria (5 listed)

Pregnant or lactating women;
Individuals with special dietary requirements that cannot comply with a uniform diet;
Suspected or confirmed allergy to any ingredients similar to the study drug or any ingredient in the study drug, or individuals with a history of allergic reactions;
Past or current severe illness/abnormality (including but not limited to cardiac/cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, malignant tumors, hematological, immune, rheumatological, neurological or psychiatric diseases), or any acute or chronic disease or physiological condition that could interfere with the trial results;
Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody; Participated in a clinical trial within the past 3 months;

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
JYP0061JYP0061 orally administered	Drug	Group A:JYP0061 15mg, Group C:JYP0061 food influence group 15mg, Group D:JYP0061 multiple ascending doses 30mg
placeboPlacebo orally administered	Drug	Group B:JYP0061 placebo comparator 15mg, Group E:JYP0061 placebo comparator food influence group 30mg, Group F:JYP0061 placebo comparator multiple ascending doses 30mg

Primary outcome

The peak plasma concentration that JYP0061 achieves after dosing.
Time frame: up to 4 weeks
Evaluate patients' electrocardiogram data to detect whether the treatment causes maximum observed concentration of drug substance in plasma

1 secondary outcome

The time to reach the maximum concentration of JYP0061 in the bloodstream after administration.
Time frame: up to 4 weeks

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 1 Dec 2023.
Individual participant dataSharing planned: No

Related trials for Healthy Subjects

Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia

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 JYP0061 in people with Healthy Subjects, run by Guangzhou JOYO 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 5 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 1 Dec 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. 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?

The peak plasma concentration that JYP0061 achieves after dosing. (time frame: up to 4 weeks). 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 NCT06137911.

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 1 Dec 2023.