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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
93
LAD106 will be administered.
Lebrikizumab will be administered.
Placebo matching LAD106 will be administered.
Centre for Human Drug Research (CHDR) Phase 1 Unit
Leiden, Netherlands
RECRUITINGPart A (SAD): Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs
Time frame: From start of study drug up to follow-up (Day 81)
Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs
Time frame: From start of study drug up to follow-up (Day 104)
Part A (SAD) and B (MAD): LAD106 Serum Concentrations Over Time
Time frame: 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
Time frame: 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): Time to Reach Maximum Serum Concentration (tmax) of LAD106
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Day 78
Part A (SAD) and B (MAD): Number of Participants with Anti-drug Antibodies (ADA) Positive Samples
Time frame: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD
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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).
Time frame: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD