Inflammatory Bowel DiseasePhase 1NCT05659953
LMT503 First-in-human SAD, MAD, and FE Study
A Phase 1 study testing LMT503 in people with Inflammatory Bowel Disease and Colitis, Ulcerative, run by Lmito Therapeutics Inc. at 1 site in Netherlands.
Trial summary
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part with integrated food effect (FE) arm, and a multiple ascending dose (MAD) part to assess the safety, tolerability, and PK of ascending single and multiple oral doses of LMT503. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease
- What is being tested?
- LMT503
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2027to 1 Dec 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age : 18 to 65 years, inclusive, at screening
- Weight : 50 to 110 kg, inclusive, at screening
- Body mass index : 18.0 to 30.0 kg/m2, inclusive, at screening
- At screening, females can be of childbearing potential (but not pregnant or lactating), or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months]); nonpregnancy will be confirmed for all females by a negative serum pregnancy test at screening, (each) admission, and follow-up.
- Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to (first) administration of the study drug until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
- Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from (first) admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
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- Supine systolic blood pressure between 90 to 140 mmHg, inclusive, diastolic blood pressure between 45 to 90 mmHg, inclusive, and a heart rate between 40 to 100 bpm, inclusive, at screening. If initial results do not meet these criteria, blood pressure may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate.
- All prescribed medication must have been stopped at least 30 days prior to (first) admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) must have been stopped at least 14 days prior to (first) admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center.
- Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and (first) admission to the clinical research center.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to (each) admission to the clinical research center.
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- Willing and able to sign the ICF.
Who cannot join
- Previous participation in the current study.
- Employee of ICON or the Sponsor.
- History of relevant drug and/or food allergies.
- Using tobacco products within 2 months prior to (first) admission.
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, gamma hydroxybutyric acid, tricyclic antidepressants, and alcohol) at screening or (at one of the) admission(s) to the clinical research center.
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- Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies.
- Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study.
- Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
- Significant and/or acute illness within 5 days prior to (the first) drug administration that may impact safety assessments, in the opinion of the Investigator.
- Unwillingness to consume the FDA breakfast.
- Unsuitable veins for infusion or blood sampling.
- Vaccination against SARS-CoV-2 planned between 2 weeks prior to (first) admission and follow-up.
- Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1 or if there was any known close contact with a person who tested positive for SARS-CoV-2 or with a COVID-19 patient within 2 weeks prior to admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
ICON plc Company - Early Development Services
Groningen, NZ, 9728
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LMT503 in Healthy Subjects
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part with integrated food effect (FE) arm, and a multiple ascending dose (MAD) part to assess the safety, tolerability, and PK of ascending single and multiple oral doses of LMT503. The study will start with the SAD part.
- Being tested
- LMT503, Placebo
- Keywords
- Macrophage Polarization, Cell metabolism modulation
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMT503Drug
Subjects will receive one of several different oral doses of LMT503 once daily
PlaceboDrug
Subjects will receive one of several different oral doses of Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| LMT503 | Experimental | Subjects receiving LMT503 orally Receives: Drug: LMT503 |
| Placebo | Placebo comparator | Subjects receiving Matched Placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events (TEAEs) in the SAD and MAD part
Incidence and severity of AEs including clinical significant changes in safety laboratory, vital signs, 12-lead ECG, continuous cardiac monitoring (telemetry), and physical examination
Measured: up to Day 17
Secondary outcomes (11)
PK parameter
Maximum observed concentration (Cmax) of LMT503 in plasma
Measured: up to Day 10, 72 hours post dose
PK parameter
Time to maximum observed concentration (Tmax) of LMT503 in plasma
Measured: up to Day 10, 72 hours post dose
PK parameter
Apparent terminal elimination half-life (t1/2) of LMT503 in plasma
Measured: up to Day 10, 72 hours post dose
PK parameter
Area under the plasma concentration-time curve from time 0 to time tau (AUC0-tau) of LMT503 in plasma
Measured: up to Day 10, 72 hours post dose
PK parameter
Terminal elimination rate constant (kel) of LMT503 in plasma
Measured: up to Day 10, 72 hours post dose
PK parameter
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) of LMT503 in plasma (SAD and FE part)
Measured: up to Day 10, 72 hours post dose
PK parameter
Area under the plasma concentration-time curve up to time t (AUC0-t) of LMT503 in plasma (SAD and FE part)
Measured: up to Day 10, 72 hours post dose
PK parameter
Concentration at the end of the dosing interval (Ctrough) of LMT503 in plasma (MAD only)
Measured: up to Day 10, 72 hours post dose
PK parameter
Cumulative amount of LMT503 excreted in urine to time t (Aeurine) (SAD and FE part)
Measured: up to Day 10, 72 hours post dose
PK parameter
Cumulative amount of LMT503 excreted in urine to time tau (Aeurine,ss) (MAD only)
Measured: up to Day 10, 72 hours post dose
Number of Treatment Emergent Adverse Events (TEAEs) in Food Effect part
Incidence and severity of AEs including clinical significant changes in safety laboratory, vital signs, 12-lead ECG, continuous cardiac monitoring (telemetry), and physical examination
Measured: up to Day 4, 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Mar 2027 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lmito Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wheeseong LEE, PhD, Study chair, Lmito Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659953
- Sponsor's protocol ID
- LMT503-101
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LMT503 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05659953
- Acronym / sponsor ID
- LMT503-101
- Keywords
- Macrophage Polarization, Cell metabolism modulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Lmito Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Dec 2022 (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 double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part with integrated food effect (FE) arm, and a multiple ascending dose (MAD) part to assess the safety, tolerability, and PK of ascending single and multiple oral doses of LMT503. The study will start with the SAD part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMT503 | Experimental | Drug: LMT503Subjects receiving LMT503 orally |
| Placebo | Placebo comparator | Drug: PlaceboSubjects receiving Matched Placebo orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age : 18 to 65 years, inclusive, at screening
- Weight : 50 to 110 kg, inclusive, at screening
- Body mass index : 18.0 to 30.0 kg/m2, inclusive, at screening
- At screening, females can be of childbearing potential (but not pregnant or lactating), or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months]); nonpregnancy will be confirmed for all females by a negative serum pregnancy test at screening, (each) admission, and follow-up.
- Female subjects of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception from at least 4 weeks prior to (first) administration of the study drug until 90 days after the follow up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
Key exclusion criteria (15 listed)
- Previous participation in the current study.
- Employee of ICON or the Sponsor.
- History of relevant drug and/or food allergies.
- Using tobacco products within 2 months prior to (first) admission.
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
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 |
|---|---|---|
| LMT503Subjects will receive one of several different oral doses of LMT503 once daily | Drug | LMT503 |
| PlaceboSubjects will receive one of several different oral doses of Placebo once daily | Drug | Placebo |
Primary outcome
Number of Treatment Emergent Adverse Events (TEAEs) in the SAD and MAD part
Time frame: up to Day 17
Incidence and severity of AEs including clinical significant changes in safety laboratory, vital signs, 12-lead ECG, continuous cardiac monitoring (telemetry), and physical examination
11 secondary outcomes
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
PK parameter
Time frame: up to Day 10, 72 hours post dose
Number of Treatment Emergent Adverse Events (TEAEs) in Food Effect part
Time frame: up to Day 4, 72 hours post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Wheeseong LEE, PhD study chair
Lmito Therapeutics Inc.
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 LMT503 in people with Inflammatory Bowel Disease and Colitis, Ulcerative, run by Lmito Therapeutics Inc. at 1 site in Netherlands.
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 13 inclusion and 15 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: opening soon, as of the sponsor's last update on 1 Sep 2026. 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 Netherlands. 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?
Contact Maria Velinova, MD, PhD (0800-0292044, info@praclinicaltrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Emergent Adverse Events (TEAEs) in the SAD and MAD part (time frame: up to Day 17). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.