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

Sponsor
Lmito Therapeutics Inc.
Study ID
NCT05659953
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Dec 21, 2022
Start date
Mar 1, 2027
Status verified
Aug 2026
Primary completion
Sep 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LMT503
    Subjects receiving LMT503 orally
  • Placebo Comparator: Placebo
    Subjects receiving Matched Placebo orally

Primary Outcome Measure

Number of Treatment Emergent Adverse Events (TEAEs) in the SAD and MAD part [ Time Frame: up to Day 17 ]

Central Contacts

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