AMLPhase 1NCT06399315

Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

A Phase 1 study testing Rabeprazole, 20mg oral and Itraconazole (200 mg) in people with AML, 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

Search all trials

Trial summary

This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: AML
What is being tested?: Rabeprazole, 20mg oral and Itraconazole (200 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 112 participants
Where: 1 siteAustralia
Study dates: 28 Jul 2023to 26 Aug 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

1. 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.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening. 3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.
4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing

Who cannot join

History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, 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.
Acute infections within 4 weeks prior to screening 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.
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

Trial locations and contacts

1 site in 1 country.

Australia1 site

Linear Clinical Research Ltd
Perth, Nedlands, WA 6009

Other trials in Australia

About this study

Official title: A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug

Read the detailed description

This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered ZE46-0134 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 6 dose levels and a multiple ascending dose (MAD) part at up to 5 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. Dosing in each cohort will start with two sentinel participants with one of the two sentinels randomised to receive ZE46-0134 and the other randomised to receive placebo. The food-effect will be investigated in SAD part and safety/PK of co-administration with rabeprazole will be investigated in MAD part.

Conditions: AML
Being tested: ZE46-0134 or placebo, Rabeprazole, 20mg oral, Itraconazole (200 mg)

What participants receive

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

ZE46-0134 or placeboDrug
Also called lomonitininb
The patients will receive ZE46-0134 or placebo
Rabeprazole, 20mg oralDrug
Rabeprazole 20 mg daily will be administered for 2 prior ZE46-0134 and 7 co-administered
Itraconazole (200 mg)Drug
Itraconazole 200 mg BID

Study groups in NCT06399315
Study group	Role	What they receive
Level 1 Single dose	Experimental	Dose level 1. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 2 Single dose	Experimental	Dose level 2. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 3 Single dose	Experimental	Dose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 2 Single dose after food	Experimental	Dose level 2 with a fat meal. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 4 Single dose	Experimental	Dose level 4. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 1 Multiple doses	Experimental	Dose level 1. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 1 Multiple doses + rabeprazole	Experimental	Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo. The drug is co-administered with rabeprazole Receives: Drug: ZE46-0134 or placebo; Drug: Rabeprazole, 20mg oral
Level 2 Multiple doses	Experimental	Dose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 3 Single dose with itraconazole	Experimental	Dose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo, in conjunction with itraconazole Receives: Drug: ZE46-0134 or placebo; Drug: Itraconazole (200 mg)
Level 5 Single dose	Experimental	Dose level 5. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 6 Single dose	Experimental	Dose level 6. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 3 Multiple doses	Experimental	Dose level 3. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 4 Multiple doses	Experimental	Dose level 4. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo
Level 5 Multiple doses	Experimental	Dose level 5. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo Receives: Drug: ZE46-0134 or placebo

What is being measured

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

Plasma concentration
Plasma concentration, ng/mL
Measured: 72 hours for SAD, 10 days for MAD

Secondary outcomes (4)

Incidence of AEs
Incidence of Adverse Events observed during the study
Measured: 8 days in SAD part, 17 days for MAD part
Incidence of drug-related AEs
Incidence of Adverse Events observed during the study deemed related to the study drug by the Investigator
Measured: 8 days in SAD part, 17 days for MAD part
Incidence of SAEs
Incidence of Serious Adverse Events observed during the study
Measured: 8 days in SAD part, 17 days for MAD part
Incidence of lab deviations
Incidence of clinically relevant deviations in the clinical laboratory parameters
Measured: Time Frame: 8 days in SAD part, 17 days for MAD part

Timeline

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

28 Jul 202326 Aug 2025

First posted3 May 2024
Study start28 Jul 2023
Primary completion30 Jun 2025
Study completion26 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AMLStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06399315
Sponsor's protocol ID: ZE46-0134-0001
Other IDs: CT-2023-CTN-03208-1
Status last verified: Dec 2025
First submitted: 1 May 2024
Last updated: 9 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All AML trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06399315
Acronym / sponsor ID: ZE46-0134-0001
Conditions: AML
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: Lomond Therapeutics Holdings, Inc.Industry (pharma, biotech, devices)
Study start: 28 Jul 2023 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 26 Aug 2025 (actual)
First posted: 3 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 14

Arm	Type	Receives
Level 1 Single dose	Experimental	Drug: ZE46-0134 or placeboDose level 1. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 2 Single dose	Experimental	Drug: ZE46-0134 or placeboDose level 2. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 3 Single dose	Experimental	Drug: ZE46-0134 or placeboDose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 2 Single dose after food	Experimental	Drug: ZE46-0134 or placeboDose level 2 with a fat meal. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 4 Single dose	Experimental	Drug: ZE46-0134 or placeboDose level 4. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 1 Multiple doses	Experimental	Drug: ZE46-0134 or placeboDose level 1. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 1 Multiple doses + rabeprazole	Experimental	Drug: ZE46-0134 or placebo, Drug: Rabeprazole, 20mg oralDose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo. The drug is co-administered with rabeprazole
Level 2 Multiple doses	Experimental	Drug: ZE46-0134 or placeboDose level 2. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 3 Single dose with itraconazole	Experimental	Drug: ZE46-0134 or placebo, Drug: Itraconazole (200 mg)Dose level 3. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo, in conjunction with itraconazole
Level 5 Single dose	Experimental	Drug: ZE46-0134 or placeboDose level 5. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 6 Single dose	Experimental	Drug: ZE46-0134 or placeboDose level 6. SAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 3 Multiple doses	Experimental	Drug: ZE46-0134 or placeboDose level 3. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 4 Multiple doses	Experimental	Drug: ZE46-0134 or placeboDose level 4. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo
Level 5 Multiple doses	Experimental	Drug: ZE46-0134 or placeboDose level 5. MAD study part. 6 participants will receive the study drug and 2 participants will receive placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

1. 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.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening. 3. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.
4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing

Key exclusion criteria (6 listed)

History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, 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.
Acute infections within 4 weeks prior to screening 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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZE46-0134 or placeboAlso: lomonitininbThe patients will receive ZE46-0134 or placebo	Drug	Level 1 Multiple doses, Level 1 Multiple doses + rabeprazole, Level 1 Single dose, Level 2 Multiple doses, Level 2 Single dose, Level 2 Single dose after food, Level 3 Multiple doses, Level 3 Single dose, Level 3 Single dose with itraconazole, Level 4 Multiple doses, Level 4 Single dose, Level 5 Multiple doses, Level 5 Single dose, Level 6 Single dose
Rabeprazole, 20mg oralRabeprazole 20 mg daily will be administered for 2 prior ZE46-0134 and 7 co-administered	Drug	Level 1 Multiple doses + rabeprazole
Itraconazole (200 mg)Itraconazole 200 mg BID	Drug	Level 3 Single dose with itraconazole

Primary outcome

Plasma concentration
Time frame: 72 hours for SAD, 10 days for MAD
Plasma concentration, ng/mL

4 secondary outcomes

Incidence of AEs
Time frame: 8 days in SAD part, 17 days for MAD part
Incidence of drug-related AEs
Time frame: 8 days in SAD part, 17 days for MAD part
Incidence of SAEs
Time frame: 8 days in SAD part, 17 days for MAD part
Incidence of lab deviations
Time frame: Time Frame: 8 days in SAD part, 17 days for MAD part

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.

Related trials for AML

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rabeprazole, 20mg oral and Itraconazole (200 mg) in people with AML, 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 3 inclusion and 6 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 9 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 concentration (time frame: 72 hours for SAD, 10 days for MAD). 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 NCT06399315.

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 9 Dec 2025.