LAD106 in Healthy Adult Volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This two-part Phase 1 protocol uses sequential cohorts of healthy adults to administer single ascending doses (Part A, up to six cohorts) and multiple ascending doses (Part B, up to three cohorts) of LAD106, with an additional cohort to explore lebrikizumab pharmacodynamics. Progression to higher dose cohorts only occurs after review of safety, tolerability, and pharmacokinetic data from earlier cohorts. Participants may receive LAD106, placebo, or (in the PD cohort) lebrikizumab, and investigators will collect blood and other samples to measure pharmacokinetics, pharmacodynamics, and immunogenicity. The study enrolls Dutch-speaking healthy men and women aged 18–45 with BMI 18–32 and is conducted at the CHDR Phase 1 Unit in Leiden under Almirall sponsorship.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Begoña Begoña
• Email: GCO@almirall.com
• Phone: +34620985953

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.