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Completed

NCT Number: NCT06137911

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200020, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

JYP0061

Drug

JYP0061 orally administered

Placebo

Drug

Placebo orally administered

Primary outcomes

  1. 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

Secondary outcomes

  1. The time to reach the maximum concentration of JYP0061 in the bloodstream after administration.

    Time frame: up to 4 weeks

    Time when the maximum concentration is achieved

Other outcomes

  1. The total drug exposure of JYP0061 from administration to an extrapolated infinite time, as represented by the area under the concentration-time curve.

    Time frame: up to 4 weeks

    Area under the concentration-time curve from time zero to infinity.in healthy subjects.

Sponsors and collaborators

Lead sponsor

Guangzhou JOYO Pharma Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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