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HealthyPhase 1NCT06787131

Clinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Administration of ZE50-0134 at 5 Dose Levels in Healthy Volunteers

A Phase 1 study testing Rabeprazole 20 mg and Itraconazole (200 mg) in people with Healthy, run by Lomond Therapeutics Holdings, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of ZE50-0134 administered orally in healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Rabeprazole 20 mg and Itraconazole (200 mg)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteAustralia
Study dates
21 May 2024to 4 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  • Adult males and females, 18 to 55 years of age (inclusive) at screening.
  • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg (males) or 45.0 kg (females) at screening.
  • Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing at the timepoints indicated in the Schedule of Assessments, including:
  • Physical examination without any clinically significant findings.
  • Systolic blood pressure in the range of 90 mm Hg to 160 mm Hg; diastolic blood pressure in the range of 40 mm Hg to 95 mm Hg.
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  • Heart rate (HR) in the range of 40 to 100 bpm after 5 minutes in a supine or semi-supine position
  • Body temperature (tympanic or oral) in the range 35.5°C to 37.7°C (inclusive).
  • No clinically significant findings in serum chemistry, hematology, coagulation and urinalysis tests as judged by the Investigator, including the following specific findings:
  • Hemoglobin and platelet count within normal ranges (as per local laboratory standard ranges), WBC count (> 3.0 x 109/L), lymphocyte count (> 1.0 x 109/L), and neutrophil count (> 1.5 x 109/L) ii. AST, ALT and total bilirubin < 1.5 x ULN (note: for participants with Gilbert's syndrome, ULN is considered to be 2.9 mg/ml).
  • Additional inclusion criterion for cohort evaluating effect of CYP3A4 inhibition only: ALT, AST, ALP and gamma-glutamyltransferase (GGT) must be normal (within reference range).
  • Triplicate 12-lead ECG (taken after the volunteer has been supine/semi-supine for at least 10 minutes) with average QTcF ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities.
  • Female volunteers must:
  • Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) level >40 IU/L at the screening visit), or
  • If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug.
  • Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug.
  • Have suitable venous access for blood sampling.
  • Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Who cannot join

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant. Note: participants with a history of fully resolved childhood asthma are permitted.
  • Acute infections within 4 weeks prior to Day -1 (nominal Cohorts 1-10) or Day -4 (nominal Cohort 11), or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
  • Presence or history of any abnormality or illness, including gastrointestinal surgery, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug. Note: participants with Gilbert's syndrome may be permitted, at the discretion of the PI (or delegate). Participants with a history of cholecystectomy may be permitted at the discretion of the PI (or delegate).
  • Any history of malignant disease in the last 5 years (excludes surgically resected skin squamous cell or basal cell carcinoma)
  • Any screening laboratory result outside the normal laboratory reference range (as confirmed upon repeated testing) and deemed clinically significant by the PI.
  • Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
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  • Use of or plans to use systemic immunosuppressive (e.g., corticosteroids by any route, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to first study drug administration.
  • Use of or plans to use agents (e.g., grapefruit and grapefruit products) that have clinically significant interaction with CYP3A4 or the use of any medications that could have a significantly impact on organ function (e.g., barbiturates, omeprazole, cimetidine) during the study or within 5 half-lives of individual agent or within 28 days (whichever is longer) prior to first study drug administration. Note: timeframe = 3 days for grapefruit and grapefruit products or other foods/drinks (e.g. pomelo) that may have a clinically significant interaction with CYP3A4.
  • History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or clinically significant arrythmia.
  • Participant is planning to have surgery between Screening and the EoS visit.
  • Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or tuberculosis (TB) at the screening visit.
  • History of latent or active TB infection, or signs or symptoms suggestive of active TB infection upon medical history and/or physical examination.
  • Estimated creatinine clearance < 60 mL/min using the Cockcroft-Gault formula.
  • History of any drug or alcohol abuse in the past 2 years defined as >21 units of alcohol per week for males and >14 units of alcohol per week for females. Where 1 unit = 360 mL of beer, 150 mL wine, or 30 mL of spirits.
  • History of alcohol consumption in the 4 days prior to dosing.
  • Positive drugs of abuse, or alcohol breath test results at the screening visit, Day -4 prior to itraconazole administration (nominal Cohort 11 only), or at check-in (Day -1).
  • Volunteer smokes more than 5 cigarettes or equivalent per week, and/or volunteer is unwilling to abstain from smoking (including use of all tobacco products or nicotine-containing products, and smoking cessation aids such as gum or patches) for 72 hours prior to Day -4 (nominal Cohort 11 only) or check-in on Day -1 and throughout the confinement period at the study site.
  • Use of any prescription medications within 14 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, including use of any over-the-counter medication (including herbal products, nutritional supplements, diet aids, vitamin supplements, minerals and hormone supplements) within 7 days or at least 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, with the exception of oral contraceptives and the occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days in one week).
  • Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would interfere with the volunteer's ability to participate in the trial.
  • Known hypersensitivity to any of the study drug ingredients.
  • Use of any inactivated vaccinations within 14 days, or any live vaccinations within 30 days prior to the first study drug administration.
  • For women of childbearing potential, a positive serum pregnancy test at the screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) on Day -4 prior to itraconazole administration (nominal Cohort 11 only), or at check-in (Day -1).
  • Females who are breastfeeding or planning to breast feed at any time during the study.
  • Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to first study drug administration, or receipt of a blood transfusion within 1 year of first study drug administration.
  • Receiving an investigational drug in another clinical trial within 30 days or 5 half-lives of the investigational agent (whichever is longer) prior to the first study drug administration.
  • Any other condition or prior therapy that in the opinion of the Investigators would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
  • Any history of long COVID infection (defined by continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least 2 months with no other explanation).
  • Additional exclusion criteria for cohort evaluating the effect of CYP3A4 inhibition only:
  • History or presence of clinically significant hypersensitivity or idiosyncratic reaction to itraconazole or other azole compounds, or any inactive ingredients.
  • History or presence of clinically significant liver disease.
  • Creatinine kinase > 1.5 x ULN at screening or on Day -1.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Scientia Clinical Research

    Sydney, Randwick NSW, 2031

Other trials in Australia

About this study

Official title: A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE50-0134 in Healthy Volunteers

A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of ZE50-0134 administered orally in healthy volunteers.

Read the detailed description

This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single administration of ZE50-0134 at 5 dose levels. The effect of food on ZE50-0134 may also be evaluated at each dose level (optional). The effects of CYP3A4 inhibition will also be evaluated in a single cohort. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.

In this study, healthy volunteers will be enrolled to receive single ascending doses of ZE50-0134 or placebo under fasted or fed conditions. ZE50-0134 will also be evaluated in conjunction with itraconazole, to evaluate the potential effects of CYP3A4 inhibition. The starting dose will be 100 mg with 5 dose levels planned.

Conditions
Healthy
Being tested
ZE50-0134 or placebo, Rabeprazole 20 mg, Itraconazole (200 mg)
Keywords
Chronic lymphocytic leukemia, refractory chronic lymphocytic leukaemia, relapsed chronic lymphocytic leukaemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, B-Cell

What participants receive

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

  • ZE50-0134 or placeboDrug

    The patients will receive ZE50-0134 or placebo.

  • Rabeprazole 20 mgDrug

    Rabeprazole 20 mg once daily (QD) on Day 1 and Day 2.

  • Itraconazole (200 mg)Drug

    Itraconazole 200 mg twice per day.

Study groups in NCT06787131
Study groupRoleWhat they receive
Level 1 Single doseExperimentalDose level 1: 6 participants will receive 100 mg ZE50-0134 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE50-0134 or placebo
Level 2 Single doseExperimentalDose level 2: 6 participants will receive 200 mg ZE50-0134 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE50-0134 or placebo
Level 3 Single doseExperimentalDose level 3: 6 participants will receive 400 mg ZE50-0134 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE50-0134 or placebo
Level 4 Single doseExperimentalDose level 4: 6 participants will receive 800 mg ZE50-0134 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE50-0134 or placebo
Level 5 Single doseExperimentalDose level 5: 6 participants will receive 1600 mg ZE50-0134 and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE50-0134 or placebo
Level 1 Single dose optionalExperimentalDose level 1: 6 participants will receive 100 mg ZE50-0134 and 2 participants will receive placebo under fed conditions.
Receives: Drug: ZE50-0134 or placebo
Level 2 Single dose optionalExperimentalDose level 2: 6 participants will receive 200 mg ZE50-0134 and 2 participants will receive placebo under fed conditions.
Receives: Drug: ZE50-0134 or placebo
Level 3 Single dose optionalExperimentalDose level 3: 6 participants will receive 400 mg ZE50-0134 and 2 participants will receive placebo under fed conditions.
Receives: Drug: ZE50-0134 or placebo
Level 4 Single dose optionalExperimentalDose level 4: 6 participants will receive 800 mg ZE50-0134 and 2 participants will receive placebo under fed conditions.
Receives: Drug: ZE50-0134 or placebo
Level 5 Single dose optionalExperimentalDose level 5: 6 participants will receive 1600 mg ZE50-0134 and 2 participants will receive placebo under fed conditions.
Receives: Drug: ZE50-0134 or placebo
Level 2 Single dose + itraconazoleExperimentalDose level 2: 6 participants will receive 200 mg ZE50-0134 and 2 participants will receive placebo under fasted conditions (to be administered in conjunction with itraconazole [200 mg itraconazole to be administered twice per day [BID] on Day -4 and once per day [QD] on Days -3 to 8, inclusive)
Receives: Drug: ZE50-0134 or placebo; Drug: Itraconazole (200 mg)
Level 3 BID dosingExperimentalDose level 3 BID dosing: 6 participants will receive 400 mg of ZE50-0134 administered BID and 2 participants will receive placebo under fasted conditions.
Receives: Drug: ZE50-0134 or placebo
Level 3 Single dose + RabeprazoleExperimentalDose level 3: 6 participants will receive 400 mg ZE50-0134 and 2 participants will receive placebo under fasted conditions (to be administered in conjunction with rabeprazole [rabeprazole 20 mg once daily (QD) on Day 1 and Day 2]).
Receives: Drug: ZE50-0134 or placebo; Drug: Rabeprazole 20 mg

What is being measured

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

  1. Plasma pharmacokinetics of ZE50-0134

    Plasma concentration, ng/mL

    Measured: Within 15 min prior to dosing with ZE50-0134/placebo to 168 hours post-dose

  2. Plasma pharmacokinetics of ZE50-0134 with and without rabeprazole (PPI)

    To evaluate and compare the PK profile of ZE50-0134 after single dose administration with and without rabeprazole (PPI) pre-dosing in healthy adult volunteers

    Measured: Within 60 min prior to dosing with ZE50-0134/placebo to 168 hours post-dose

Secondary outcomes (1)

  1. Safety of ZE50-0134

    Incidence of AEs/SAEs (serious adverse events)including significant changes from baseline in body weight, vital signs, electrocardiogram parameters and laboratory assessments qualifying and reported as AEs.

    Measured: From the signing of the consent form until day 8 for all dose levels except level 2 + Itraconazole and until day 11 for dose level 2 + Itraconazole.

Timeline

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

  1. First posted22 Jan 2025
  2. Study start21 May 2024
  3. Primary completion4 Jul 2025
  4. Study completion4 Jul 2025

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06787131
Sponsor's protocol ID
ZE50-0134-0001
Status last verified
Nov 2025
First submitted
16 Jan 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rabeprazole 20 mg and Itraconazole (200 mg) in people with Healthy, run by Lomond Therapeutics Holdings, Inc. at 1 site in Australia.

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 18 inclusion and 31 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: finished, as of the sponsor's last update on 5 Dec 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 Australia. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Plasma pharmacokinetics of ZE50-0134 (time frame: Within 15 min prior to dosing with ZE50-0134/placebo to 168 hours post-dose). The study lists 2 primary outcomes in all. 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 NCT06787131.

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 5 Dec 2025.

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