Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LCA-0061 · 1 trial · 2 indications
Percentage of participants by cohort and treatment arm with a TEAE. A TEAE is defined as a new condition or worsening of a preexisting condition that appeared after start of treatment.
Percentage of participants by cohort and treatment arm discontinuing treatment and/or study
Percentage of participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 2, 3, 4 or 5 TEAE by cohort and treatment arm
Percentage of participants, by cohort and treatment arm, with clinically significant abnormal laboratory values, ECGs, and vital signs
| Arm | Type | Description |
|---|---|---|
| Part A - LCA-0061 (SAD) | EXPERIMENTAL | Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061 |
| Part B - LCA-0061 (MAD) | EXPERIMENTAL | Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061 |
| Part A (SAD) | PLACEBO_COMPARATOR | Participants in cohorts 1-5 will receive a single dose of Placebo |
| Part B (MAD) | PLACEBO_COMPARATOR | Participants in cohorts 1-4 will receive multiple doses of Placebo |
| Name | Type | Description |
|---|---|---|
| LCA-0061 | DRUG | LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation |
| Placebo | DRUG | Placebo |
Key Inclusion Criteria: Part A (SAD) and Part B (MAD) 1. Must provide written consent for participation 2. Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive) and body weight ≥ 50kg at screening 3. Have elevated serum IgE at screening 4. Female participants of childbeari...