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Recruiting NCT07471932

A Study of LAD106 in Healthy Adult Participants

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LAD106, Lebrikizumab, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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.

Interventions

  • Drug LAD106
    LAD106 will be administered.
  • Drug Lebrikizumab
    Lebrikizumab will be administered.
  • Other Placebo
    Placebo matching LAD106 will be administered.

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • 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 [Time frame: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Centre for Human Drug Research (CHDR) Phase 1 Unit — Leiden

Identifiers

NCT: NCT07471932 · M-27312-01 · 2025-523328-31-00 · CHDR2521

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗