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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: JYP0061; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200020
      • Shanghai Xuhui District Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A:JYP0061 15mg; Experimental: JYP0061 Single ascending dose	Drug: JYP0061; JYP0061 orally administered
Placebo Comparator: Group B:JYP0061 placebo comparator 15mg; Placebo comparator: JYP0061 placebo comparator Single ascending dose	Drug: placebo; Placebo orally administered
Experimental: Group C:JYP0061 food influence group 15mg; Food influence group	Drug: JYP0061; JYP0061 orally administered
Experimental: Group D:JYP0061 multiple ascending doses 30mg; Multiple ascending doses	Drug: JYP0061; JYP0061 orally administered
Placebo Comparator: Group E:JYP0061 placebo comparator food influence group 30mg; Food influence group	Drug: placebo; Placebo orally administered
Placebo Comparator: Group F:JYP0061 placebo comparator multiple ascending doses 30mg; Multiple ascending doses	Drug: placebo; Placebo orally administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to reach the maximum concentration of JYP0061 in the bloodstream after administration.	Time when the maximum concentration is achieved	up to 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total drug exposure of JYP0061 from administration to an extrapolated infinite time, as represented by the area under the concentration-time curve.	Area under the concentration-time curve from time zero to infinity.in healthy subjects.	up to 4 weeks

Collaborators and Investigators

• Sponsor: Guangzhou JOYO Pharma Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2021
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): November 9, 2022

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JYP0061M101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No