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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMT503 | Experimental | Subjects receiving LMT503 orally |
|
| Placebo | Placebo Comparator | Subjects receiving Matched Placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMT503 | Drug | Subjects will receive one of several different oral doses of LMT503 once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter | Maximum observed concentration (Cmax) of LMT503 in plasma | up to Day 10, 72 hours post dose |
| PK parameter | Time to maximum observed concentration (Tmax) of LMT503 in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Velinova, MD, PhD | Contact | 0800-0292044 | info@praclinicaltrials.com |
| Name | Affiliation | Role |
|---|---|---|
| Wheeseong LEE, PhD | Lmito Therapeutics Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON plc Company - Early Development Services | Groningen | NZ | 9728 | Netherlands |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Placebo |
| Drug |
Subjects will receive one of several different oral doses of Placebo once daily |
|
| up to Day 10, 72 hours post dose |
| PK parameter | Apparent terminal elimination half-life (t1/2) of LMT503 in plasma | 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 | up to Day 10, 72 hours post dose |
| PK parameter | Terminal elimination rate constant (kel) of LMT503 in plasma | 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) | 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) | 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) | 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) | up to Day 10, 72 hours post dose |
| PK parameter | Cumulative amount of LMT503 excreted in urine to time tau (Aeurine,ss) (MAD only) | 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 | up to Day 4, 72 hours post dose |
| D003092 | Colitis |
| D003108 | Colonic Diseases |