A Study of LAD106 in Healthy Adult Participants

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: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: LAD106; Other: Placebo; Drug: Lebrikizumab

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: Interventional
• Enrollment (Estimated): 93
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Begoña Begoña; Phone Number: +34620985953; Email: GCO@almirall.com
• Study Contact Backup: Name: Estrella Estrella, +34620985953; Email: GCO@almirall.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Investigators: Study Director: Study Director, Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: lebrikizumab
• Other Study ID 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