Healthy VolunteersPhase 1NCT07471932
A Study of LAD106 in Healthy Adult Participants
A Phase 1 study testing LAD106 and Lebrikizumab in people with Healthy Volunteers, run by Almirall, S.A. at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LAD106 and Lebrikizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2026to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estrella Estrella, +34620985953 contact
Netherlands1 site, 1 recruiting
- Recruiting
Centre for Human Drug Research (CHDR) Phase 1 Unit
Leiden
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- LAD106, Lebrikizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAD106Drug
LAD106 will be administered.
LebrikizumabDrug
Also called Ebglyss®
Lebrikizumab will be administered.
PlaceboOther
Placebo matching LAD106 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part A: LAD106 (Cohort 1) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 1). Receives: Drug: LAD106 |
| Part A: LAD106 (Cohort 2) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 2). Receives: Drug: LAD106 |
| Part A: LAD106 (Cohort 3) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 3). Receives: Drug: LAD106 |
| Part A: LAD106 (Cohort 4) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 4). Receives: Drug: LAD106 |
| Part A: LAD106 (Cohort 5) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 5). Receives: Drug: LAD106 |
| Part A: LAD106 (Cohort 6) | Experimental | Participants will receive a single ascending dose of LAD106 (Dose 6). Receives: Drug: LAD106 |
| Part A: Placebo | Placebo comparator | Participants will receive a single dose of placebo matching LAD106. Receives: Other: Placebo |
| Part B: LAD106 (Cohort A) | Experimental | Participants will receive a multiple ascending dose of LAD106 (Dose 1). Receives: Drug: LAD106 |
| Part B: LAD106 (Cohort B) | Experimental | Participants will receive a multiple ascending dose of LAD106 (Dose 2). Receives: Drug: LAD106 |
| Part B: LAD106 (Cohort C) | Experimental | Participants will receive a multiple ascending dose of LAD106 (Dose 3). Receives: Drug: LAD106 |
| Part B: Lebrikizumab (Cohort 0) | Active comparator | Participants will receive lebrikizumab. Receives: Drug: Lebrikizumab |
| Part B: Placebo | Placebo comparator | Participants will receive a multiple dose of placebo matching LAD106. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A (SAD): Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Severity of TEAEs
Measured: From start of study drug up to follow-up (Day 81)
Part B (MAD): Number of Participants with TEAEs and Severity of TEAEs
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 78
Part A (SAD) and B (MAD): Number of Participants with Anti-drug Antibodies (ADA) Positive Samples
Measured: 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
Titer of confirmed ADA positive samples are determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Pre-dose up to Day 78 for SAD and up to Day 99 for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start17 Feb 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471932
- Sponsor's protocol ID
- M-27312-01
- Other IDs
- 2025-523328-31-00, CHDR2521, 2025
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07471932
- Acronym / sponsor ID
- M-27312-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A: LAD106 (Cohort 1) | Experimental | Drug: LAD106Participants will receive a single ascending dose of LAD106 (Dose 1). |
| Part A: LAD106 (Cohort 2) | Experimental | Drug: LAD106Participants will receive a single ascending dose of LAD106 (Dose 2). |
| Part A: LAD106 (Cohort 3) | Experimental | Drug: LAD106Participants will receive a single ascending dose of LAD106 (Dose 3). |
| Part A: LAD106 (Cohort 4) | Experimental | Drug: LAD106Participants will receive a single ascending dose of LAD106 (Dose 4). |
| Part A: LAD106 (Cohort 5) | Experimental | Drug: LAD106Participants will receive a single ascending dose of LAD106 (Dose 5). |
| Part A: LAD106 (Cohort 6) | Experimental | Drug: LAD106Participants will receive a single ascending dose of LAD106 (Dose 6). |
| Part A: Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo matching LAD106. |
| Part B: LAD106 (Cohort A) | Experimental | Drug: LAD106Participants will receive a multiple ascending dose of LAD106 (Dose 1). |
| Part B: LAD106 (Cohort B) | Experimental | Drug: LAD106Participants will receive a multiple ascending dose of LAD106 (Dose 2). |
| Part B: LAD106 (Cohort C) | Experimental | Drug: LAD106Participants will receive a multiple ascending dose of LAD106 (Dose 3). |
| Part B: Lebrikizumab (Cohort 0) | Active comparator | Drug: LebrikizumabParticipants will receive lebrikizumab. |
| Part B: Placebo | Placebo comparator | Other: PlaceboParticipants will receive a multiple dose of placebo matching LAD106. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAD106LAD106 will be administered. | Drug | 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) |
| LebrikizumabAlso: Ebglyss®Lebrikizumab will be administered. | Drug | Part B: Lebrikizumab (Cohort 0) |
| PlaceboPlacebo matching LAD106 will be administered. | Other | Part A: Placebo, Part B: Placebo |
Primary outcome
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)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Estrella Estrella, +34620985953 contact
Study Director study director
Almirall, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LAD106 and Lebrikizumab in people with Healthy Volunteers, run by Almirall, S.A. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Begoña Begoña (+34620985953, GCO@almirall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.