LAD106 in Healthy Adult Volunteers

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

This test gives single and multiple doses of experimental drug LAD106 to healthy adults to see if it is safe, how the body handles it, and whether it triggers immune responses.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Almirall, S.A. (Industry-sponsored)
• Drugs / interventions: lebrikizumab
• Locations: 1 site (Leiden)
• Trial ID: NCT07471932 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy Dutch-speaking men and women aged 18–45 with BMI between 18 and 32 kg/m2 who agree to study procedures and required contraception measures.

Not a fit: People with active or chronic medical conditions, outside the age or BMI limits, pregnant or breastfeeding, or who cannot communicate in Dutch are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could define safe dose ranges and how the body processes LAD106 to support later patient trials.

How similar studies have performed: Single- and multiple-ascending-dose designs are standard in early drug development and have successfully established safety and PK for many investigational drugs, while lebrikizumab's pharmacodynamic profile has been characterized in other clinical programs.

Eligibility criteria

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 this trial is running

Leiden

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

Study contacts

• Study coordinator: Begoña Begoña

Conditions Healthy Volunteers