Status:
COMPLETED
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
Lead Sponsor:
Guangzhou JOYO Pharma Co., Ltd
Conditions:
Healthy Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2022
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06137911
Start Date
September 26 2021
End Date
November 9 2022
Last Update
December 1 2023
Active Locations (1)
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1
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China, 200020