A Study of LAD106 in Healthy Adult Participants

NCT07471932 | Recruiting Phase 1

• 3 other identifiers: M-27312-012025-523328-31-00CHDR2521
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Part A (SAD): Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs

  From start of study drug up to follow-up (Day 81)

• Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs

  From start of study drug up to follow-up (Day 104)

Secondary Outcomes (8)

• Part A (SAD) and B (MAD): LAD106 Serum Concentrations Over Time

  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

  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

  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

  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

  Pre-dose up to Day 78 post-dose for SAD and up to Day 99 post-dose for MAD

Study Arms (12)

Part A: LAD106 (Cohort 1)

EXPERIMENTAL

Participants will receive a single ascending dose of LAD106 (Dose 1).

Drug: LAD106

Part A: LAD106 (Cohort 2)

EXPERIMENTAL

Participants will receive a single ascending dose of LAD106 (Dose 2).

Drug: LAD106

Part A: LAD106 (Cohort 3)

EXPERIMENTAL

Participants will receive a single ascending dose of LAD106 (Dose 3).

Drug: LAD106

Part A: LAD106 (Cohort 4)

EXPERIMENTAL

Participants will receive a single ascending dose of LAD106 (Dose 4).

Drug: LAD106

Part A: LAD106 (Cohort 5)

EXPERIMENTAL

Participants will receive a single ascending dose of LAD106 (Dose 5).

Drug: LAD106

Part A: LAD106 (Cohort 6)

EXPERIMENTAL

Participants will receive a single ascending dose of LAD106 (Dose 6).

Drug: LAD106

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo matching LAD106.

Other: Placebo

Part B: LAD106 (Cohort A)

EXPERIMENTAL

Participants will receive a multiple ascending dose of LAD106 (Dose 1).

Drug: LAD106

Part B: LAD106 (Cohort B)

EXPERIMENTAL

Participants will receive a multiple ascending dose of LAD106 (Dose 2).

Drug: LAD106

Part B: LAD106 (Cohort C)

EXPERIMENTAL

Participants will receive a multiple ascending dose of LAD106 (Dose 3).

Drug: LAD106

Part B: Lebrikizumab (Cohort 0)

ACTIVE COMPARATOR

Participants will receive lebrikizumab.

Drug: Lebrikizumab

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive a multiple dose of placebo matching LAD106.

Other: Placebo

Interventions

LAD106 DRUG

LAD106 will be administered.

Part A: LAD106 (Cohort 1); Part A: LAD106 (Cohort 2); Part A: LAD106 (Cohort 3); Part A: LAD106 (Cohort 4); Part A: LAD106 (Cohort 5); Part A: LAD106 (Cohort 6); Part B: LAD106 (Cohort A); Part B: LAD106 (Cohort B); Part B: LAD106 (Cohort C)

Lebrikizumab DRUG

Lebrikizumab will be administered.

Also known as: Ebglyss®

Part B: Lebrikizumab (Cohort 0)

Placebo OTHER

Placebo matching LAD106 will be administered.

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Centre for Human Drug Research (CHDR) Phase 1 Unit

Leiden, Netherlands

RECRUITING

MeSH Terms

Interventions

lebrikizumab

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Central Study Contacts

Begoña Begoña

CONTACT

+34620985953; GCO@almirall.com

Estrella Estrella, +34620985953

CONTACT

GCO@almirall.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 13, 2026
• Study Start: February 17, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)