Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of YD0293 in Healthy Subjects

NCT07098091 | Enrolling By Invitation Phase 1

• 1 other identifier: PY-YD0293-I-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, single- and multiple-dose escalating study with a food-effect component, designed to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of YD0293 tablets following a single oral dose in healthy subjects, as well as the effect of food on PK parameters and the potential effect on the QT interval. The study also aims to assess the safety, tolerability, and PK profile of YD0293 tablets following multiple oral doses in healthy subjects.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• To assess the safety of YD0293 in healthy participants

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Single ascending dose(SAD): day1 to day15; Multiple ascending dose(MAD): day1 to day39; Food effect(FE): day1 to day21

Secondary Outcomes (6)

• To assess the pharmacokinetic parameters of YD0293 in healthy participants

  Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11

• To assess the pharmacokinetic parameters of YD0293 in healthy participants

  Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11

• To assess the pharmacokinetic parameters of YD0293 in healthy participants

  Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11

• To assess the pharmacokinetic parameters of YD0293 in healthy participants

  Single ascending dose(SAD): day1 to day5; Multiple ascending dose(MAD): day1 to day32; Food effect(FE): day1 to day11

• To assess the changes in QT/QTc intervals following a single oral dose of YD0293 tablets

  Single ascending dose(SAD): day1 to day2

Study Arms (2)

YD0293

EXPERIMENTAL

Single dose ascending(SAD): participants will be randomized to receive a single dose of YD0293, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Multiple ascending dose(MAD): participants will be randomized to receive muliple doses of YD0293, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of YD0293.

Drug: YD0293

YD0293 placebo

PLACEBO COMPARATOR

Single dose ascending(SAD): participants will be randomized to receive a single dose of placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Multiple ascending dose(MAD): participants will be randomized to receive muliple doses of placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort. Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of YD0293.

Drug: YD0293 placebo

Interventions

YD0293 DRUG

YD0293 tablet for oral administration

YD0293

YD0293 placebo DRUG

YD0293 placebo tablet for oral administration

YD0293 placebo

Eligibility Criteria

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

You may qualify if:

• Healthy subjects, both male and female, in each group;
• years old\< = age\< = 45 years old;
• The weight of men shall not be less than 50kg, and the weight of women shall not be less than 45kg. Body mass index (BMI) = weight (kg) / height \^2 (m\^2), 19.0kg/m2\< = body mass index (BMI) \< = 26.0 kg/m\^2;
• During the screening period, those who have undergone vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virological examination, chest X-ray, B-ultrasound and blood pregnancy (female), and the results show no abnormality or abnormality without clinical significance;
• The results of the 12-lead ECG during the screening period are consistent with normal cardiac conduction and function, including: Sinus rhythm, 50\< = heart rate \< = 100 bpm; b. QT interval (QTcF) corrected using Fridericia method \<=450 ms; c. QRS\<=120 ms; d. PR interval \<=210 ms; e. The ECG morphology is normal, and there are no clinically significant changes as judged by the investigator.
• The subject agrees to have no fertility plan and voluntarily take effective contraceptive measures during the trial period and within 3 months after the last dose;
• The subjects fully understand the purpose, nature, methods and possible adverse events of the trial, voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

• Pregnant or breastfeeding females;
• History of chronic diseases or clinical abnormalities that need to be excluded, including but not limited to disorders of the central nervous system, cardiovascular system, kidneys, liver, gastrointestinal tract, respiratory system, hematologic system, metabolic disorders, and musculoskeletal system, or any other physiological condition that could interfere with study results;
• Active infectious disease requiring antimicrobial treatment at screening;
• Undergone surgery within 3 months prior to screening and not fully recovered, as judged by the investigator;
• Previous or current diagnosis of functional dipeptidyl peptidase-1 (DPP1) deficiency leading to periodontitis or palmoplantar keratoderma, with current signs of gingivitis/periodontitis or a history of palm or sole hyperkeratosis or erythema;
• Confirmed clinically significant allergic reactions (e.g., to food, any component of the investigational drug or placebo, atopic reactions, asthma attacks), which the investigator believes would interfere with the subject's participation in the trial;
• Clinically relevant immunosuppressive diseases (including but not limited to immunodeficiency disorders);
• Abnormal liver function test results (e.g., AST, ALT, GGT) deemed clinically significant by the investigator;
• Abnormal creatine kinase MB (CK-MB) levels deemed clinically significant by the investigator;
• Participation in another drug or medical device clinical trial within 3 months prior to screening;
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus IgG antibody, HIV antibodies and p24 antigen, or anti-treponemal antibody at screening, and considered clinically significant by the investigator;
• Presence of tattoos or scars on any part of the skin that would affect safety assessments, as judged by the investigator;
• Received vaccination within 1 month prior to screening or during the screening period;
• History of blood donation within 3 months prior to screening, or plans to donate blood or blood components during the study period, or total blood loss \>= 200 mL due to bleeding (excluding menstrual bleeding);
• Taken any medication within 2 weeks prior to dosing, including strong inhibitors or inducers of CYP3A4 or CYP2D6, traditional Chinese medicine, weight-loss drugs, or supplements;

Sponsors & Collaborators

• Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Study Officials

• Jie Pan

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 1, 2025
• Study Start: February 26, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-05

Locations

CN (1)