AzTrials
AzTrials

Healthy ParticipantsPhase 1NCT07098091

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

A Phase 1 study testing YD0293 in people with Healthy Participants, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
YD0293
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteChina
Study dates
26 Feb 2025to 31 Dec 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects, both male and female, in each group;
  • 18 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.

Who cannot join

  • 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;
Show all 27Show fewer
  • 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;
  • Consumed excessive amounts of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months prior to screening;
  • Regular alcohol consumption (more than 14 units per week; 1 unit = 360 mL beer or 45 mL of 40% spirits or 150 mL wine) within 6 months prior to screening or during the screening period, and unable to abstain from alcohol during the trial;
  • Smoked >= 5 cigarettes per day within 6 months prior to screening, or unable to stop using tobacco products during the trial;
  • Unable to refrain from smoking, consuming alcohol (or alcoholic beverages), tea, or coffee from 48 hours before dosing until the last blood draw;
  • Consumed large quantities of grapefruit, pomelo, star fruit, mango, or dragon fruit drinks or foods within 14 days prior to screening or within 48 hours before the first dose;
  • History of drug abuse within 5 years prior to screening or positive urine drug screen (morphine, THC, methamphetamine, MDMA, ketamine);
  • Engaged in strenuous exercise within 1 week prior to dosing, or unable to stop strenuous exercise during the trial;
  • History of torsades de pointes or other risk factors, or family history of short QT syndrome, long QT syndrome, unexplained sudden death or drowning under age 40, or SIDS in first-degree relatives (biological parents, siblings, or children), or presence of implanted pacemaker or ICD;
  • Applicable only to FE studies: Special dietary requirements that prevent adherence to a standardized diet or difficulty swallowing;
  • Unable to tolerate venipuncture or difficult with blood sampling;
  • Any other condition deemed unsuitable for participation by the investigator;
  • Subject requests withdrawal from the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of YD0293 Tablets in Healthy Subjects

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.

Being tested
YD0293, YD0293 placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YD0293Drug

    YD0293 tablet for oral administration

  • YD0293 placeboDrug

    YD0293 placebo tablet for oral administration

Study groups in NCT07098091
Study groupRoleWhat they receive
YD0293ExperimentalSingle 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.
Receives: Drug: YD0293
YD0293 placeboPlacebo comparatorSingle 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.
Receives: Drug: YD0293 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the safety of YD0293 in healthy participants

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

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

Secondary outcomes (6)

  1. To assess the pharmacokinetic parameters of YD0293 in healthy participants

    Time to reach maximum concentration (Tmax)

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

  2. To assess the pharmacokinetic parameters of YD0293 in healthy participants

    Maximum concentration (Cmax)

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

  3. To assess the pharmacokinetic parameters of YD0293 in healthy participants

    Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)

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

  4. To assess the pharmacokinetic parameters of YD0293 in healthy participants

    Elimination half time (T1/2)

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

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

    Measured: Single ascending dose(SAD): day1 to day2

  6. To assess the pharmacodynamic characteristic of YD0293 in healthy participants

    Change in active neutrophil elastase concentrations in blood after multiple oral doses of YD0293 from baseline

    Measured: Multiple ascending dose(MAD): day1 to day32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start26 Feb 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07098091
Sponsor's protocol ID
PY-YD0293-I-01
Status last verified
May 2025
First submitted
16 Jul 2025
Last updated
17 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YD0293 in people with Healthy Participants, run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety of YD0293 in healthy participants (time frame: Single ascending dose(SAD): day1 to day15; Multiple ascending dose(MAD): day1 to day39; Food effect(FE): day1 to day21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07098091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in