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RecruitingNCT07471932Updated May 15, 2026

A Study of LAD106 in Healthy Adult Participants

A Phase 1 interventional study of LAD106 and Lebrikizumab in Healthy Volunteers, sponsored by Almirall, S.A.. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Almirall, S.A. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Volunteers
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
93 participants (estimated)

Study arms

  • Experimental
    Part A: LAD106 (Cohort 1)

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

    Drug: LAD106

  • Experimental
    Part A: LAD106 (Cohort 2)

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

    Drug: LAD106

  • Experimental
    Part A: LAD106 (Cohort 3)

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

    Drug: LAD106

  • Experimental
    Part A: LAD106 (Cohort 4)

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

    Drug: LAD106

  • Experimental
    Part A: LAD106 (Cohort 5)

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

    Drug: LAD106

  • Experimental
    Part A: LAD106 (Cohort 6)

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

    Drug: LAD106

  • Placebo comparator
    Part A: Placebo

    Participants will receive a single dose of placebo matching LAD106.

    Other: Placebo

  • Experimental
    Part B: LAD106 (Cohort A)

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

    Drug: LAD106

  • Experimental
    Part B: LAD106 (Cohort B)

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

    Drug: LAD106

  • Experimental
    Part B: LAD106 (Cohort C)

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

    Drug: LAD106

  • Active comparator
    Part B: Lebrikizumab (Cohort 0)

    Participants will receive lebrikizumab.

    Drug: Lebrikizumab

  • Placebo comparator
    Part B: Placebo

    Participants will receive a multiple dose of placebo matching LAD106.

    Other: Placebo

Interventions

  • DrugLAD106

    LAD106 will be administered.

  • DrugLebrikizumab

    Lebrikizumab will be administered.

    Also known as: Ebglyss®

  • OtherPlacebo

    Placebo matching LAD106 will be administered.

05

What researchers measure

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

    Titer of confirmed ADA positive samples are determined by enzyme-linked immunosorbent assay (ELISA).

    Time frame: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD

06

Study locations

1 of 1 sites recruiting
  • Centre for Human Drug Research (CHDR) Phase 1 Unit
    Leiden, Netherlands
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07471932
Lead sponsor
Almirall, S.A.
Responsible party
Sponsor
First posted
Mar 13, 2026
Start date
Feb 17, 2026
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
May 15, 2026

Study contacts

Begoña Begoña
Contact
GCO@almirall.com
+34620985953
Estrella Estrella, +34620985953
Contact
GCO@almirall.com
Study Director
study director · Almirall, S.A.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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