Centre for Human Drug Research (CHDR) Phase 1 Unit
Leiden, Netherlands
Location status: Recruiting
NCT Number: NCT07471932
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Leiden, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LAD106 will be administered.
Lebrikizumab will be administered.
Other names: Ebglyss®
Placebo matching LAD106 will be administered.
Time frame: From start of study drug up to follow-up (Day 81)
Time frame: From start of study drug up to follow-up (Day 104)
Time frame: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
Time frame: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
Time frame: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
Time frame: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
Time frame: Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD
Time frame: Up to Day 78
Time frame: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD
Time frame: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD
Titer of confirmed ADA positive samples are determined by enzyme-linked immunosorbent assay (ELISA).
Contact information is provided by the study sponsor or research team.
Begoña Begoña
CONTACT
Estrella Estrella, +34620985953
CONTACT
Almirall, S.A.
Industry
A Phase 1, Randomized, Two-part, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacodynamics of LAD106 in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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