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Not yet recruitingNCT07841522Updated Sep 25, 2026

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW243040 in Healthy Participants

A Phase 1 interventional study of HW243040 and HW243040 Matching Placebo in Healthy Volunteers, sponsored by The Third Xiangya Hospital of Central South University. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by The Third Xiangya Hospital of Central South University · Phase 1, Interventional, and Other

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HW243040 in healthy participants. The study consists of two parts: Part A (Single Ascending Dose, SAD) and food effect study, and Part B (Multiple Ascending Dose, MAD). A total of approximately 98 healthy participants will be enrolled.

Read the detailed description

This is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HW243040, a novel angiotensin II type 2 receptor (AT2R) antagonist, in healthy participants. Preclinical data have demonstrated that HW243040 exhibits good analgesic efficacy in neuropathic pain models with a favorable safety profile, supporting its further clinical development. This study does not aim to explore the maximum tolerated dose (MTD) but focuses on characterizing the safety and PK profile across a range of doses.

The study is divided into two main parts: Part A (Single Ascending Dose, SAD, combined with a Food Effect evaluation) and Part B (Multiple Ascending Dose, MAD) . A total of approximately 98 healthy participants are planned for enrollment across both parts.

Part A: SAD and Food Effect Study Part A consists of 6 dose cohorts: 50 mg, 150 mg, 300 mg, 600 mg, 900 mg, and 1200 mg. Except for the 600 mg cohort, each cohort enrolls 10 participants (8 receiving active HW243040 and 2 receiving placebo) under fasting conditions. The 600 mg cohort enrolls 18 participants (16 active, 2 placebo) and utilizes a two-period, two-sequence crossover design to evaluate the effect of a high-fat, high-calorie meal on the PK of HW243040. In this cohort, participants receive the study drug under fasting conditions in one period and under fed conditions in the other, with a 7-day washout between periods. Dose escalation proceeds sequentially from the lowest to the highest dose, with dose progression decisions made by a Safety Review Committee (SRC) based on review of safety and available PK data from the preceding cohort. Dose escalation will be halted if predefined stopping criteria are met (e.g., ≥1/2 participants with moderate related AEs, ≥1/3 with severe related AEs, or any related SAE).

Part B: MAD Study Based on the safety and PK results from Part A, Part B evaluates three dose levels of HW243040 administered twice daily (BID). The planned dose levels are 150 mg, 300 mg, and 600 mg BID. Each cohort enrolls 10 participants (8 active, 2 placebo). Participants receive the study drug for 5 consecutive days (morning and evening, approximately 12 hours apart, for a total of 9 administrations, with only the morning dose given on Day 5). The final dosing regimen, duration, and sampling schedule for Part B may be adjusted based on emerging data from Part A.

Study Population:

Healthy male and female participants aged 18 to 55 years, with a body mass index (BMI) between 19 and 26 kg/m², and body weight ≥50 kg for males and ≥45 kg for females. Participants must be willing to undergo pain testing procedures and comply with the study requirements.

Intervention and Blinding:

HW243040 is formulated as oral tablets in 50 mg and 200 mg strengths. Matching placebo tablets are provided. The study is double-blinded; participants, investigators, site staff, and outcome assessors will be blinded to treatment allocation. Randomization is performed using a block randomization method with a 8:2 (active:placebo) ratio for most cohorts (and 8:1 for the 600 mg SAD cohort).

Study Procedures and Assessments:

The study comprises a screening period (Day -7 to Day -1), a treatment/observation period, and a follow-up period (for unresolved AEs).

Safety Assessments: Include monitoring of adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, 12-lead electrocardiograms (ECGs), clinical laboratory tests (hematology, biochemistry, urinalysis, coagulation, and thyroid function), and pregnancy tests for females of childbearing potential. A C-QTc sub-study is planned for cohorts at doses ≥300 mg (including the 600 mg cohort, Sequence A only) to explore the relationship between HW243040 plasma concentrations and changes in QTcF interval.

Pharmacokinetic Assessments:

SAD/FE (non-600mg cohorts): Blood samples are collected at 13 time points from pre-dose to 72 hours post-dose.

SAD/FE (600mg cohort): Blood samples are collected at 26 time points across two periods (up to 72 hours post-dose per period).

MAD: Blood samples are collected on Day 1 (pre-dose to 12 hours), pre-dose on Days 3, 4, and 5, and intensively on Day 5 up to 72 hours post final dose (25 time points total).

Urine and Feces (Exploratory): Full urine and fecal samples are collected from participants in Sequence A of the 600 mg cohort during the first period for metabolite profiling and excretion mass balance exploration.

Pharmacodynamic Assessments:

PD evaluations are performed using standardized pain tests, including Pressure Pain Threshold (PPT) measured by a pressure algometer and Pain Tolerance Time (PTT) measured by the cold pressor test (immersion of hand in ice water, maximum 120 seconds). PD assessments are conducted at pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dose.

Pharmacokinetic Parameters:

Key PK parameters calculated using non-compartmental analysis include: C\~max\~, T\~max\~, AUC\~0-t\~, AUC\~0-inf\~, t\~1/2\~, CL/F, and Vz/F (SAD); and additionally C\~trough,ss\~, AUC\~tau,ss\~, and accumulation ratios (R\~ac\~) for MAD.

Statistical Analysis:

Analyses will be performed using SAS (Version 9.4 or higher). The Safety Analysis Set (SS) will be used for all safety summaries. PK parameters will be summarized descriptively by dose group. For the food effect evaluation, a linear mixed-effects model (with sequence, period, and treatment as fixed effects and participant as random effect) will be applied to log-transformed exposure parameters (AUC\~0-t\~, AUC\~0-inf\~, C\~max\~) to calculate geometric mean ratios and 90% confidence intervals. PD endpoints, C-QTc relationship, and dose proportionality will be explored descriptively or via appropriate modeling approaches (e.g., power model, linear mixed-effects model).

Study Duration and Follow-up:

Participants will be confined to the clinical unit from Day -1 through the end of the observation period (Day 4 for most SAD cohorts; Day 11 for the 600 mg cohort; Day 8 for MAD cohorts). All participants with ongoing AEs at discharge will be followed until resolution, return to baseline, stabilization, or loss to follow-up.

The study is being conducted at a single center, The Third Xiangya Hospital of Central South University, Changsha, China, under the sponsorship of Hubei Bio-Pharmaceutical Industrial Technology Research Institute Co., Ltd.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • HW243040
  • Angiotensin II Type 2 Receptor Antagonist
  • AT2R Antagonist
  • Healthy Volunteers
  • Pharmacokinetics
  • Single Ascending Dose
  • Multiple Ascending Dose
  • Food Effect
03

In context

Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 99 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed form prior to any study-related procedures, with full understanding of the study content, procedures, and potential adverse reactions, and ability to complete the study as per protocol requirements.
  2. Healthy male or female, aged ≥ 18 and ≤ 55 years on the day of signing the informed consent form.
  3. Body weight: males ≥ 50 kg, females ≥ 45 kg; (BMI) between 19 and 26 kg/m² inclusive (BMI = weight (kg) / height² (m²)).
  4. Vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, and thyroid function), and 12-lead (ECG) findings are normal or clinically insignificant at screening and baseline.
  5. Abdominal ultrasound, thyroid ultrasound, and chest X-ray findings are normal or clinically insignificant at screening.
  6. Willing and able to undergo pain testing procedures and trained qualified.
  7. Female participants of and male participants with partners of childbearing potential must have adopted measures within 2 weeks prior to signing the informed consent form, and must agree to remain abstinent or use highly effective contraceptive methods from the signing of the informed consent form through the end of the follow-up period.
  8. Female participants of childbearing potential must agree to use highly effective contraceptive methods during the study and for 3 months after the last dose; serum pregnancy test must be negative at screening and baseline, and must not be breastfeeding. Male participants must agree to use highly effective contraceptive methods and refrain from sperm donation during the study and for 3 months after the last dose.

Exclusion criteria

Exclusion Criteria:

-

1. Presence of any of the following diseases or treatment history:

  1. Current or previous history of any disease involving the urinary, cardiovascular, endocrine, neurological, digestive, respiratory, hematopoietic, immune, psychiatric, or metabolic systems, or any other condition that, in the investigator's judgment, may interfere with the study results, such as intestinal diseases (including irritable bowel syndrome) and urinary tract infections.
  2. History of (except for cancers that have been cured or in remission for ≥ 5 years, radically resected basal cell or squamous cell skin carcinoma, in situ cervical carcinoma, and resected colon polyps).
  3. Any condition or disease that, in the investigator's judgment, may affect the absorption, metabolism, and/or excretion of the study drug.
  4. Severe infection, severe trauma, or major surgery within 3 months prior to screening or baseline, or planned surgery during the study period.
  5. Use of any medication (including prescription drugs, over-the-counter drugs, herbal medicines, dietary supplements, vitamin A and its derivatives, etc., except for routine vitamins and occasional use of acetaminophen) within 2 weeks prior to screening or baseline, or still within 5 half-lives of the drug at screening or baseline (whichever is longer); or planned use of non-study medications during the study period.
  6. Participation in any other drug or medical device clinical trial within 3 months prior to screening or baseline, or planned participation during the study period, or still within 5 half-lives of the drug at screening or baseline (whichever is longer).

2. Any of the following laboratory findings at screening:

  1. Sitting systolic blood pressure \< 90 mmHg or sitting diastolic blood pressure \< 50 mmHg at screening or baseline.
  2. Orthostatic hypotension confirmed by repeat measurement within 15 minutes at screening or baseline.
  3. Clinically significant 12-lead abnormalities at screening or baseline; > 450 ms for males or QTcF > 460 ms for females.
  4. Positive for surface antigen (HBsAg), (HIV) antibody, syphilis antibody, or virus (HCV) antibody at screening.

3. General conditions:

  1. Blood donation or significant blood loss (≥ 400 mL) within 8 weeks prior to screening or baseline, or blood transfusion within 4 weeks prior to screening or baseline; or intention to donate blood during the study period.
  2. Vaccination within 2 weeks prior to screening or baseline, or planned vaccination during the study period.
  3. Smoking history (average > 5 cigarettes per day) within 4 weeks prior to screening or baseline, or inability to refrain from using any tobacco products during the study period.
  4. Average daily alcohol intake > 15 g within 4 weeks prior to screening or baseline (15 g alcohol is equivalent to approximately 450 mL beer, 150 mL wine, or 50 mL liquor), or inability to abstain from alcohol during the study period; or positive breath alcohol test at baseline.
  5. History of drug abuse or dependence prior to screening or baseline; or positive urine drug screen at baseline.
  6. Excessive consumption of tea, coffee, or caffeinated beverages (average > 8 cups per day, 250 mL per cup) within 6 months prior to screening or baseline.
  7. Consumption of special foods (such as grapefruit, grapefruit juice, or foods/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeinated foods or beverages, etc.) within 48 hours prior to baseline.
  8. Special dietary requirements or inability to comply with the standardized diet provided by the study center.
  9. Dysphagia, difficulty in venous blood collection, or physical condition unable to tolerate intensive blood sampling.
  10. Known allergy to any component of the investigational medicinal product; history of allergic diseases or allergic constitution.
  11. Use of strong or moderate inhibitors/inducers of CYP2C9, or any inhibitors of P-gp, OATP1B1, OATP1B3, or OAT3 within 30 days prior to screening or planned during the study period.
  12. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study, including but not limited to any physiological or psychological condition that may increase the risk of the study, affect the participant's compliance with the protocol, or affect the participant's ability to complete the study.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
98 participants (estimated)

Study arms

  • Experimental
    HW243040 50mg Single Dose

    Participants receive a single oral dose of HW243040 50mg (one 50mg tablet) under fasting conditions on Day 1.

    Drug: HW243040

  • Experimental
    HW243040 150mg Single Dose

    Participants receive a single oral dose of HW243040 150mg (three 50mg tablets) under fasting conditions on Day 1.

    Drug: HW243040

  • Experimental
    HW243040 300mg Single Dose

    Participants receive a single oral dose of HW243040 300mg (six 50mg tablets or one 200mg + two 50mg tablets) under fasting conditions on Day 1.

    Drug: HW243040

  • Experimental
    HW243040 600mg Single Dose (Fasting and Fed)

    Participants receive a single oral dose of HW243040 600mg (three 200mg tablets) in a two-period crossover design: one dose under fasting conditions and one dose under fed (high-fat, high-calorie meal) conditions, with a 7-day washout period between doses.

    Drug: HW243040

  • Experimental
    HW243040 900mg Single Dose

    Participants receive a single oral dose of HW243040 900mg (one 200mg + one 50mg tablets, total 4.5 tablets) under fasting conditions on Day 1.

    Drug: HW243040

  • Experimental
    HW243040 1200mg Single Dose

    Participants receive a single oral dose of HW243040 1200mg (six 200mg tablets) under fasting conditions on Day 1.

    Drug: HW243040

  • Placebo comparator
    Placebo Single Dose

    Participants receive a single oral dose of HW243040 matching placebo tablets (number of tablets matching the corresponding active dose group) under fasting conditions on Day 1.

    Drug: HW243040 Matching Placebo

  • Experimental
    HW243040 150mg BID Multiple Doses

    Participants receive HW243040 150mg (three 50mg tablets) orally twice daily (every 12 hours) for 5 days (9 doses total, Day 1 to Day 5 morning) under fasting conditions.

    Drug: HW243040

  • Experimental
    HW243040 300mg BID Multiple Doses

    Participants receive HW243040 300mg (six 50mg tablets or one 200mg + two 50mg tablets) orally twice daily (every 12 hours) for 5 days (9 doses total, Day 1 to Day 5 morning) under fasting conditions.

    Drug: HW243040

  • Experimental
    HW243040 600mg BID Multiple Doses

    Participants receive HW243040 600mg (three 200mg tablets) orally twice daily (every 12 hours) for 5 days (9 doses total, Day 1 to Day 5 morning) under fasting conditions.

    Drug: HW243040

  • Placebo comparator
    Placebo BID Multiple Doses

    Participants receive HW243040 matching placebo tablets orally twice daily (every 12 hours) for 5 days (9 doses total, Day 1 to Day 5 morning) under fasting conditions.

    Drug: HW243040 Matching Placebo

Interventions

  • DrugHW243040

    HW243040 tablets, 50mg and 200mg规格, administered orally. Doses range from 50mg to 1200mg as a single dose in Part A, or 150mg to 600mg twice daily for 5 days in Part B. Administered with 240mL water under fasting or fed (high-fat, high-calorie meal) conditions as specified per arm.

  • DrugHW243040 Matching Placebo

    HW243040 matching placebo tablets, 50mg and 200mg规格, identical in appearance to HW243040 active tablets. Administered orally with 240mL water under the same conditions as the corresponding active dose arm.

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Number of participants with TEAEs, including serious adverse events (SAEs), assessed by CTCAE v5.0.

    Time frame: From signing of informed consent form through follow-up period (until AE resolution; up to Day 4 for SAD 50/150/300/900/1200 mg, Day 11 for 600 mg FE, Day 8 for MAD cohorts).

  2. Number of Participants with Clinically Significant Vital Signs Changes

    Time frame: Baseline (Day -1) to End of Study; measured at screening, Day -1, pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 hours post-dose (schedule varies per cohort).

  3. Number of Participants with Clinically Significant Laboratory Abnormalities

    Time frame: Baseline (Screening) to End of Study (Day 4 for SAD 50/150/300/900/1200 mg; Day 11 for 600 mg FE; Day 8 for MAD).

  4. Number of Participants with Clinically Significant 12-lead ECG Abnormalities

    Time frame: Baseline (Day -1) to End of Study; measured at screening, Day -1, pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 hours post-dose (schedule varies per cohort).

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) Following Single Ascending Dose Administration

    Cmax of HW243040 in plasma following single ascending dose administration, measured by validated LC-MS/MS method.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose.

  2. Time to Maximum Observed Plasma Concentration (Tmax) of HW243040 Following Single Ascending Dose Administration

    Tmax of HW243040 in plasma following single ascending dose administration, determined directly from concentration-time data.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose.

  3. Apparent Terminal Elimination Half-life (t1/2) of HW243040 Following Single Ascending Dose Administration

    Terminal elimination half-life of HW243040 in plasma following single ascending dose administration, calculated as ln(2)/λz.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose.

  4. Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of HW243040 Following Single Ascending Dose Administration

    AUC0-t of HW243040 in plasma following single ascending dose administration, calculated using the linear-up/log-down trapezoidal method. Unit: h\*ng/mL.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose.

  5. Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of HW243040 Following Single Ascending Dose Administration

    AUC0-inf of HW243040 in plasma following single ascending dose administration, calculated as AUC0-t + Clast/λz.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose.

  6. Apparent Total Clearance (CL/F) of HW243040 Following Single Ascending Dose Administration

    Apparent total clearance of HW243040 from plasma following single ascending dose administration, calculated as Dose/AUC0-inf.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose.

  7. Apparent Volume of Distribution (Vz/F) of HW243040 Following Single Ascending Dose Administration

    Apparent volume of distribution of HW243040 during the terminal phase following single ascending dose administration, calculated as Dose/(AUC0-inf × λz).

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose.

  8. Maximum Observed Plasma Concentration (Cmax) of HW243040 Following Single Dose in Fed and Fasted States

    Cmax of HW243040 in plasma following single dose in fed and fasted states, measured by validated LC-MS/MS method.

    Time frame: Period 1 (Day 1) and Period 2 (Day 8): pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose in each period (two-way crossover, fasted vs fed).

  9. Time to Maximum Observed Plasma Concentration (Tmax) of HW243040 Following Single Dose in Fed and Fasted States

    Tmax of HW243040 in plasma following single dose in fed and fasted states.

    Time frame: Period 1 (Day 1) and Period 2 (Day 8): pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose in each period (two-way crossover, fasted vs fed).

  10. Apparent Terminal Elimination Half-life (t1/2) of HW243040 Following Single Dose in Fed and Fasted States

    Terminal elimination half-life of HW243040 in plasma following single dose in fed and fasted states, calculated as ln(2)/λz.

    Time frame: Period 1 (Day 1) and Period 2 (Day 8): pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose in each period (two-way crossover, fasted vs fed).

  11. Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of HW243040 Following Single Dose in Fed and Fasted States

    AUC0-t of HW243040 in plasma following single dose in fed and fasted states, calculated by linear-up/log-down trapezoidal method.

    Time frame: Period 1 (Day 1) and Period 2 (Day 8): pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose in each period (two-way crossover, fasted vs fed).

  12. Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of HW243040 Following Single Dose in Fed and Fasted States

    AUC0-inf of HW243040 in plasma following single dose in fed and fasted states, calculated as AUC0-t + Clast/λz.

    Time frame: Period 1 (Day 1) and Period 2 (Day 8): pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose in each period (two-way crossover, fasted vs fed).

  13. Apparent Total Clearance (CL/F) of HW243040 Following Single Dose in Fed and Fasted States

    Apparent total clearance of HW243040 in plasma following single dose in fed and fasted states, calculated as Dose/AUC0-inf.

    Time frame: Period 1 (Day 1) and Period 2 (Day 8): pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose in each period (two-way crossover, fasted vs fed).

  14. Apparent Volume of Distribution (Vz/F) of HW243040 Following Single Dose in Fed and Fasted States

    Apparent volume of distribution of HW243040 in plasma following single dose in fed and fasted states, calculated as Dose/(AUC0-inf × λz).

    Time frame: Period 1 (Day 1) and Period 2 (Day 8): pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours post-dose in each period (two-way crossover, fasted vs fed).

  15. Maximum Observed Plasma Concentration (Cmax) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    Cmax of HW243040 in plasma on Day 1 after the first dose of multiple ascending dose administration, measured by validated LC-MS/MS method.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  16. Time to Maximum Observed Plasma Concentration (Tmax) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    Tmax of HW243040 in plasma on Day 1 after the first dose of multiple ascending dose administration.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  17. Area Under the Plasma Concentration-Time Curve from Time Zero to 12 Hours (AUC0-12h) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    AUC0-12h of HW243040 in plasma on Day 1, calculated by linear-up/log-down trapezoidal method.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  18. Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    AUC0-inf of HW243040 in plasma on Day 1, calculated as AUC0-t + Clast/λz.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  19. Apparent Total Clearance (CL/F) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    Apparent total clearance of HW243040 on Day 1, calculated as Dose/AUC0-inf.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  20. Apparent Volume of Distribution (Vz/F) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    Apparent volume of distribution of HW243040 on Day 1, calculated as Dose/(AUC0-inf × λz).

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  21. Apparent Terminal Elimination Half-life (t1/2) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    Terminal elimination half-life of HW243040 on Day 1, calculated as ln(2)/λz.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  22. Area Under the Plasma Concentration-Time Curve over One Dosing Interval (AUC0-tau) of HW243040 on Day 1 of Multiple Ascending Dose Administration

    AUC0-tau of HW243040 in plasma on Day 1, covering the 12-hour dosing interval, calculated by linear-up/log-down trapezoidal method.

    Time frame: Day 1: pre-dose (within 30 minutes) and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose (12-hour sample is pre-dose for second administration).

  23. Area Under the Plasma Concentration-Time Curve over a Dosing Interval at Steady State (AUCtau,ss) of HW243040

    AUC over one dosing interval at steady state on Day 5 of multiple ascending dose administration, calculated by linear-up/log-down trapezoidal method.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  24. Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration at Steady State (AUC0-t,ss) of HW243040

    AUC0-t at steady state on Day 5 of multiple ascending dose administration, calculated by linear-up/log-down trapezoidal method.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  25. Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity at Steady State (AUC0-inf,ss) of HW243040

    AUC0-inf at steady state on Day 5 of multiple ascending dose administration, calculated as AUC0-t + Clast/λz.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  26. Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of HW243040

    Tmax at steady state on Day 5 of multiple ascending dose administration.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  27. Apparent Terminal Elimination Half-life (t1/2) of HW243040 at Steady State

    Terminal elimination half-life at steady state on Day 5 of multiple ascending dose administration, calculated as ln(2)/λz.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  28. Apparent Clearance at Steady State (CLss/F) of HW243040

    Apparent clearance at steady state on Day 5 of multiple ascending dose administration, calculated as Dose/AUCtau,ss.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  29. Apparent Volume of Distribution at Steady State (Vz/F) of HW243040

    Apparent volume of distribution at steady state on Day 5 of multiple ascending dose administration, calculated as Dose/(AUCtau,ss × λz).

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  30. Trough Concentration at Steady State (Ctrough,ss) of HW243040

    Trough plasma concentration at steady state on Day 5 of multiple ascending dose administration.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  31. Peak Concentration at Steady State (Cmax,ss) of HW243040

    Peak plasma concentration at steady state on Day 5 of multiple ascending dose administration.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  32. Accumulation Ratio (Rac) of HW243040 at Steady State

    Accumulation ratio based on AUC (Rac,AUC) and Cmax (Rac,Cmax) at steady state on Day 5 of multiple ascending dose administration.

    Time frame: Day 3, Day 4, and Day 5: pre-dose (morning troughs); Day 5: pre-dose and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-morning dose; plus 24 hours (Day 6), 48 hours (Day 7), and 72 hours (Day 8) post-morning dose on Day 5.

  33. Cumulative Amount of Unchanged HW243040 Excreted in Urine (Ae)

    Cumulative amount of unchanged HW243040 excreted in urine, measured by validated LC-MS/MS method.

    Time frame: Period 1 (Day 1): pre-dose (within 12 hours) and 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours post-dose.

  34. Cumulative Amount of Unchanged HW243040 Excreted in Feces (Ae)

    Cumulative amount of unchanged HW243040 excreted in feces, measured by validated LC-MS/MS method.

    Time frame: Period 1 (Day 1): pre-dose (within 12 hours) and 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours post-dose.

  35. Fraction of Unchanged HW243040 Excreted in Urine (fe)

    Fraction of unchanged HW243040 excreted in urine, calculated as Ae/dose.

    Time frame: Period 1 (Day 1): pre-dose (within 12 hours) and 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours post-dose.

  36. Fraction of Unchanged HW243040 Excreted in Feces (fe)

    Fraction of unchanged HW243040 excreted in feces, calculated as Ae/dose.

    Time frame: Period 1 (Day 1): pre-dose (within 12 hours) and 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours post-dose.

  37. Renal Clearance (CLR) of HW243040

    Renal clearance of HW243040, calculated as cumulative amount excreted in urine divided by AUC.

    Time frame: Period 1 (Day 1): pre-dose (within 12 hours) and 0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours post-dose.

Other outcomes

  1. Change from Baseline in QTcF Interval (ΔQTcF and ΔΔQTcF)

    Change from baseline in Fridericia-corrected QT interval (ΔQTcF) and placebo-corrected change from baseline (ΔΔQTcF).

    Time frame: Day 1: pre-dose at -30, -20, -10 minutes; and 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose (300 mg and above cohorts; 600 mg cohort only Sequence A in Period 1).

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared because this is a first-in-human or early-stage clinical trial involving a novel investigational drug. The data contain proprietary and confidential information that could compromise ongoing patent applications and future commercial development. Public data sharing at this stage may also violate our confidentiality agreements with the contract research organization (CRO) and regulatory authorities. Therefore, IPD sharing is not feasible until the drug receives market approval or the primary study results are fully published.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841522
Lead sponsor
The Third Xiangya Hospital of Central South University
Responsible party
Guoping Yang (Professor of Clinical Pharmacology, The Third Xiangya Hospital of Central South University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Sep 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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