A Study of LAD106 in Healthy Adult Participants

May 14, 2026 updated by: Almirall, S.A.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Centre for Human Drug Research (CHDR) Phase 1 Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Signed informed consent and willing and able to comply with the study protocol.
  2. Healthy men or women,18 to 45 years of age (inclusive) at screening.
  3. Female participants agree to use effective contraception.
  4. Male volunteers agree to use barrier protection when they engage in sexual relations with women of child-bearing potential (WOCBP) or lactating women.
  5. Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m^2), inclusive, and with a minimum bodyweight of 50 kg.
  6. Has the ability to communicate well with the Investigator in Dutch language and willing to comply with the study restrictions.

Exclusion Criteria:

  1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator.
  2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results.
  3. Use of any medications (prescription or over-the-counter [OTC]), within 14 days prior to IMP dosing or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day).
  4. If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: LAD106 (Cohort 1)
Participants will receive a single ascending dose of LAD106 (Dose 1).
Drug: LAD106
LAD106 will be administered.
Experimental: Part A: LAD106 (Cohort 2)
Participants will receive a single ascending dose of LAD106 (Dose 2).
Drug: LAD106
LAD106 will be administered.
Experimental: Part A: LAD106 (Cohort 3)
Participants will receive a single ascending dose of LAD106 (Dose 3).
Drug: LAD106
LAD106 will be administered.
Experimental: Part A: LAD106 (Cohort 4)
Participants will receive a single ascending dose of LAD106 (Dose 4).
Drug: LAD106
LAD106 will be administered.
Experimental: Part A: LAD106 (Cohort 5)
Participants will receive a single ascending dose of LAD106 (Dose 5).
Drug: LAD106
LAD106 will be administered.
Experimental: Part A: LAD106 (Cohort 6)
Participants will receive a single ascending dose of LAD106 (Dose 6).
Drug: LAD106
LAD106 will be administered.
Placebo Comparator: Part A: Placebo
Participants will receive a single dose of placebo matching LAD106.
Other: Placebo
Placebo matching LAD106 will be administered.
Experimental: Part B: LAD106 (Cohort A)
Participants will receive a multiple ascending dose of LAD106 (Dose 1).
Drug: LAD106
LAD106 will be administered.
Experimental: Part B: LAD106 (Cohort B)
Participants will receive a multiple ascending dose of LAD106 (Dose 2).
Drug: LAD106
LAD106 will be administered.
Experimental: Part B: LAD106 (Cohort C)
Participants will receive a multiple ascending dose of LAD106 (Dose 3).
Drug: LAD106
LAD106 will be administered.
Active Comparator: Part B: Lebrikizumab (Cohort 0)
Participants will receive lebrikizumab.
Drug: Lebrikizumab
Lebrikizumab will be administered.
Other Names:
  • Ebglyss®
Placebo Comparator: Part B: Placebo
Participants will receive a multiple dose of placebo matching LAD106.
Other: Placebo
Placebo matching LAD106 will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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)
From start of study drug up to follow-up (Day 104)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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).
Pre-dose up to Day 78 for SAD and up to Day 99 for MAD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Almirall, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Almirall, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M-27312-01
  • 2025-523328-31-00 (Ctis)
  • CHDR2521 (Other Identifier: Centre for Human Drug Research (CHDR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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