A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of JYP0061 in Healthy Adult Subjects

Sponsor

Guangzhou JOYO Pharma Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT06137911

Collaborator

(none)

Enrollment

Location

Arms

13.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: JYP0061 Drug: placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 1 Trial

Actual Study Start Date :

Sep 26, 2021

Actual Primary Completion Date :

Nov 9, 2022

Actual Study Completion Date :

Nov 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: JYP0061 SAD 15mg Experimental: JYP0061 Single ascending dose	Drug: JYP0061 JYP0061 orally administered
Placebo Comparator: Placebo comparator: JYP0061 placebo comparator 15mg Placebo comparator: JYP0061 placebo comparator Single ascending dose	Drug: placebo Placebo orally administered
Experimental: JYP0061 food influence group FIG 15mg Food influence group	Drug: JYP0061 JYP0061 orally administered
Experimental: JYP0061 multiple ascending doses 30mg Multiple ascending doses	Drug: JYP0061 JYP0061 orally administered
Placebo Comparator: JYP0061 placebo comparator food influence group 30mg Food influence group	Drug: placebo Placebo orally administered
Placebo Comparator: JYP0061 placebo comparator multiple ascending doses 30mg Multiple ascending doses	Drug: placebo Placebo orally administered

Outcome Measures

Primary Outcome Measures

Cmax of JYP0061 [up to 4 weeks]
evaluate patients' electrocardiogram data to detect whether the treatment causes Maximum observed concentration of drug substance in plasma

Secondary Outcome Measures

Tmax of JYP0061 [up to 4 weeks]
Time when the maximum concentration is acheived

Other Outcome Measures

AUC0-∞ of JYP0061 [up to 4 weeks]
Area under the concentration-time curve from time zero to infinity.in healthy subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai	China	200020

Sponsors and Collaborators

Guangzhou JOYO Pharma Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangzhou JOYO Pharma Co., Ltd

ClinicalTrials.gov Identifier:

NCT06137911

Other Study ID Numbers:

JYP0061M101

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Apr 1, 2023

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:

Study Results

No Results Posted as of Nov 18, 2023