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

NCT ID: NCT06137911

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-26

Study Completion Date

2022-11-09

Brief Summary

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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.

Detailed Description

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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

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A:JYP0061 15mg

Experimental: JYP0061 Single ascending dose

Group Type EXPERIMENTAL

JYP0061

Intervention Type DRUG

JYP0061 orally administered

Group B:JYP0061 placebo comparator 15mg

Placebo comparator: JYP0061 placebo comparator Single ascending dose

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo orally administered

Group C:JYP0061 food influence group 15mg

Food influence group

Group Type EXPERIMENTAL

JYP0061

Intervention Type DRUG

JYP0061 orally administered

Group D:JYP0061 multiple ascending doses 30mg

Multiple ascending doses

Group Type EXPERIMENTAL

JYP0061

Intervention Type DRUG

JYP0061 orally administered

Group E:JYP0061 placebo comparator food influence group 30mg

Food influence group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo orally administered

Group F:JYP0061 placebo comparator multiple ascending doses 30mg

Multiple ascending doses

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo orally administered

Interventions

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JYP0061

JYP0061 orally administered

Intervention Type DRUG

placebo

Placebo orally administered

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Guangzhou JOYO Pharma Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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JYP0061M101

Identifier Type: -

Identifier Source: org_study_id