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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137911
• Other study ID #: JYP0061M101
• Status: Completed
• Phase: Phase 1
• Start date: September 26, 2021
• Est. completion date: November 9, 2022

Study information

• Verified date: April 2023
• Source: Guangzhou JOYO Pharma Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 9, 2022
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• JYP0061
JYP0061 orally administered
• placebo
Placebo orally administered

Locations

Country	Name	City	State
China	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou JOYO Pharma Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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