RecruitingPhase 1NCT07471932

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


Sponsor

Almirall, S.A.

Enrollment

93 participants

Start Date

Feb 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria6

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

Exclusion Criteria4

  • 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.
  • Clinically significant abnormalities, as judged by the Investigator, in laboratory test results.
  • 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).
  • If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study.

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Interventions

DRUGLAD106

LAD106 will be administered.

DRUGLebrikizumab

Lebrikizumab will be administered.

OTHERPlacebo

Placebo matching LAD106 will be administered.


Locations(1)

Centre for Human Drug Research (CHDR) Phase 1 Unit

Leiden, Netherlands

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NCT07471932


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