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

NCT06137911 | Completed Phase 1

• 1 other identifier: JYP0061M101
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  up to 4 weeks

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.

  up to 4 weeks

Study Arms (6)

Group A:JYP0061 15mg

EXPERIMENTAL

Experimental: JYP0061 Single ascending dose

Drug: JYP0061

Group B:JYP0061 placebo comparator 15mg

PLACEBO COMPARATOR

Placebo comparator: JYP0061 placebo comparator Single ascending dose

Drug: placebo

Group C:JYP0061 food influence group 15mg

EXPERIMENTAL

Food influence group

Drug: JYP0061

Group D:JYP0061 multiple ascending doses 30mg

EXPERIMENTAL

Multiple ascending doses

Drug: JYP0061

Group E:JYP0061 placebo comparator food influence group 30mg

PLACEBO COMPARATOR

Food influence group

Drug: placebo

Group F:JYP0061 placebo comparator multiple ascending doses 30mg

PLACEBO COMPARATOR

Multiple ascending doses

Drug: placebo

Interventions

JYP0061 DRUG

JYP0061 orally administered

Group A:JYP0061 15mg; Group C:JYP0061 food influence group 15mg; Group D:JYP0061 multiple ascending doses 30mg

placebo DRUG

Placebo orally administered

Group B:JYP0061 placebo comparator 15mg; Group E:JYP0061 placebo comparator food influence group 30mg; Group F:JYP0061 placebo comparator multiple ascending doses 30mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200020, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 18, 2023
• Study Start: September 26, 2021
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)