Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LBS-008 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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 |
| SAD - Cohort 5 | EXPERIMENTAL | 25 mg LBS-008 or placebo |
| MAD - Cohort 1 | EXPERIMENTAL | 10 mg LBS-008 or placebo |
| MAD - Cohort 2 | EXPERIMENTAL | 25 mg LBS-008 or placebo |
| MAD - Cohort 3 | EXPERIMENTAL | 5 mg LBS-008 or placebo |
| MAD - Cohort 4 | EXPERIMENTAL | 12 mg LBS-008 or placebo |
| Name | Type | Description |
|---|---|---|
| LBS-008 | DRUG | LBS-008 oral capsules |
| Placebos | DRUG | Oral capsules |
Inclusion Criteria: * The subject is male or female, 18 to 65 years of age, inclusive, at screening. * The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures. * The subject is willing and able to remain i...
LBS-008 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety and tolerability after single and multiple doses. The drug is not approved and remains under investigation.
The specific molecular target of LBS-008 has not been disclosed in the available information. It is a small molecule modality, but its mechanism of action is not specified. The drug is being evaluated in early-stage clinical trials for safety and tolerability.
LBS-008 is being developed by Belite Bio, Inc, a biopharmaceutical company traded on the stock exchange under the ticker symbol BLTE. The company is conducting clinical research on this investigational small molecule.
LBS-008 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is still being studied for safety and tolerability in healthy volunteers.
LBS-008 has one completed clinical trial, identified as NCT03735810, titled "Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses." This Phase 1 study enrolled 71 participants in Australia and was a randomized, double-blind, controlled trial.
LBS-008 is not FDA approved. It is an investigational drug in Phase 1 clinical development. The drug has received a Fast Track designation from the FDA, which is intended to facilitate development and expedite review, but approval has not been granted.