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| Name | Class |
|---|---|
| Belite Bio, Inc | INDUSTRY |
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This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD - Cohort 1 | Experimental | 50 mg LBS-008 or placebo |
|
| SAD - Cohort 2 | Experimental | 100 mg LBS-008 or placebo |
|
| SAD - Cohort 3 | Experimental | 200 mg LBS-008 or placebo |
|
| SAD - Cohort 4 | Experimental | 400 mg LBS-008 or placebo |
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| SAD - Cohort 5 | Experimental | 25 mg LBS-008 or placebo |
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| MAD - Cohort 1 | Experimental | 10 mg LBS-008 or placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBS-008 | Drug | LBS-008 oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t) | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 | |
| Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf) | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 | |
| Maximum observed plasma concentration (Cmax) | SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28 | |
| Time to maximum observed plasma concentration (Tmax) | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 | |
| Terminal elimination rate constant | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 | |
| Terminal phase half-life (t1/2) | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 | |
| Apparent total body clearance (CL/F) | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 | |
| Apparent volume of distribution (Vz/F) | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 | |
| Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation. | SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Perth | 6009 | Australia |
After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
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| MAD - Cohort 2 | Experimental | 25 mg LBS-008 or placebo |
|
| MAD - Cohort 3 | Experimental | 5 mg LBS-008 or placebo |
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| MAD - Cohort 4 | Experimental | 12 mg LBS-008 or placebo |
|
| Placebos | Drug | Oral capsules |
|