Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07471932

A Study 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research (CHDR) Phase 1 Unit

Leiden, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

LAD106

Drug

LAD106 will be administered.

Lebrikizumab

Drug

Lebrikizumab will be administered.

Other names: Ebglyss®

Placebo

Other

Placebo matching LAD106 will be administered.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Part A (SAD): Absolute Bioavailability of LAD106

    Time frame: Up to Day 78

  7. 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

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Begoña Begoña

CONTACT

[email protected]

+34620985953

Estrella Estrella, +34620985953

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2026
Registry last updated
May 15, 2026

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.

Published trials that share one or more normalized conditions with this study.