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LMT503 First-in-human SAD, MAD, and FE Study

ConditionsInflammatory Bowel DiseaseColitis, UlcerativeCrohn Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLmito Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • LMT503

    Drug

    Subjects will receive one of several different oral doses of LMT503 once daily

  • Placebo

    Drug

    Subjects will receive one of several different oral doses of Placebo once daily

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: LMT503Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to Day 17

Secondary outcomes

1

PK parameter

Maximum observed concentration (Cmax) of LMT503 in plasma

Time frame
up to Day 10, 72 hours post dose
2

PK parameter

Time to maximum observed concentration (Tmax) of LMT503 in plasma

Time frame
up to Day 10, 72 hours post dose
3

PK parameter

Apparent terminal elimination half-life (t1/2) of LMT503 in plasma

Time frame
up to Day 10, 72 hours post dose
4

PK parameter

Area under the plasma concentration-time curve from time 0 to time tau (AUC0-tau) of LMT503 in plasma

Time frame
up to Day 10, 72 hours post dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lmito Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: