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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523328-31-00 | EU Trial (CTIS) Number | ||
| CHDR2521 | Other Identifier | Centre for Human Drug Research (CHDR) |
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The main aim of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of single ascending doses of LAD106 (Part A) and multiple ascending doses of LAD106 (Part B) in human healthy participants.
This is a 2-part study. Part A will comprise up to 6 cohorts of healthy adult participants and investigate single ascending doses of LAD106. Part B will comprise up to 3 cohorts of healthy adult participants to evaluate multiple ascending doses of LAD106, and 1 cohort will investigate the pharmacodynamic effects of lebrikizumab. The study is based on sequential cohorts for escalation of single and multiple doses of LAD106, where progression to the next cohort is only started following a review of safety, tolerability, and pharmacokinetic data of earlier study cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LAD106 (Cohort 1) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 1). |
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| Part A: LAD106 (Cohort 2) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 2). |
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| Part A: LAD106 (Cohort 3) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 3). |
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| Part A: LAD106 (Cohort 4) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 4). |
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| Part A: LAD106 (Cohort 5) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 5). |
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| Part A: LAD106 (Cohort 6) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 6). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAD106 | Drug | LAD106 will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A (SAD): Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs | From start of study drug up to follow-up (Day 81) | |
| Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs | From start of study drug up to follow-up (Day 104) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A (SAD) and B (MAD): LAD106 Serum Concentrations Over Time | Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD | |
| Part A (SAD) and B (MAD): Maximum Serum Concentration (Cmax) of LAD106 | Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Begoña Begoña | Contact | +34620985953 | GCO@almirall.com | |
| Estrella Estrella, +34620985953 | Contact | GCO@almirall.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Almirall, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research (CHDR) Phase 1 Unit | Recruiting | Leiden | Netherlands |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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| Part A: Placebo | Placebo Comparator | Participants will receive a single dose of placebo matching LAD106. |
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| Part B: LAD106 (Cohort A) | Experimental | Participants will receive a multiple ascending dose of LAD106 (Dose 1). |
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| Part B: LAD106 (Cohort B) | Experimental | Participants will receive a multiple ascending dose of LAD106 (Dose 2). |
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| Part B: LAD106 (Cohort C) | Experimental | Participants will receive a multiple ascending dose of LAD106 (Dose 3). |
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| Part B: Lebrikizumab (Cohort 0) | Active Comparator | Participants will receive lebrikizumab. |
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| Part B: Placebo | Placebo Comparator | Participants will receive a multiple dose of placebo matching LAD106. |
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| Lebrikizumab | Drug | Lebrikizumab will be administered. |
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| Placebo | Other | Placebo matching LAD106 will be administered. |
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| Part A (SAD) and B (MAD): Time to Reach Maximum Serum Concentration (tmax) of LAD106 | Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD |
| Part A (SAD) and B (MAD): Area Under the Serum Concentration-time Curve (AUC) of LAD106 | Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD |
| Part A (SAD) and B (MAD): Elimination Half-life (t½) of LAD106 | Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD |
| Part A (SAD): Absolute Bioavailability of LAD106 | Up to Day 78 |
| Part A (SAD) and B (MAD): Number of Participants with Anti-drug Antibodies (ADA) Positive Samples | Pre-dose up to Day 78 for SAD and up to Day 99 for MAD |
| Part A (SAD) and B (MAD): Titer of Confirmed ADA Positive Samples | Titer of confirmed ADA positive samples are determined by enzyme-linked immunosorbent assay (ELISA). | Pre-dose up to Day 78 for SAD and up to Day 99 for MAD |