A Phase 1 interventional study of LAD106 and Lebrikizumab in Healthy Volunteers, sponsored by Almirall, S.A.. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Almirall, S.A. · Phase 1, Interventional, and Treatment
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.
Almirall, S.A. is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single ascending dose of LAD106 (Dose 1).
Drug: LAD106
Participants will receive a single ascending dose of LAD106 (Dose 2).
Drug: LAD106
Participants will receive a single ascending dose of LAD106 (Dose 3).
Drug: LAD106
Participants will receive a single ascending dose of LAD106 (Dose 4).
Drug: LAD106
Participants will receive a single ascending dose of LAD106 (Dose 5).
Drug: LAD106
Participants will receive a single ascending dose of LAD106 (Dose 6).
Drug: LAD106
Participants will receive a single dose of placebo matching LAD106.
Other: Placebo
Participants will receive a multiple ascending dose of LAD106 (Dose 1).
Drug: LAD106
Participants will receive a multiple ascending dose of LAD106 (Dose 2).
Drug: LAD106
Participants will receive a multiple ascending dose of LAD106 (Dose 3).
Drug: LAD106
Participants will receive lebrikizumab.
Drug: Lebrikizumab
Participants will receive a multiple dose of placebo matching LAD106.
Other: Placebo
LAD106 will be administered.
Lebrikizumab will be administered.
Also known as: Ebglyss®
Placebo matching LAD106 will be administered.
Part 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
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
Plan to share: No
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