Healthy VolunteersPhase 1NCT06200597
A Single and Multiple Ascending Dose Study of LAD603 in Healthy Subjects
A Phase 1 study testing LAD603 in people with Healthy Volunteers, run by Almirall, S.A. at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple ascending doses of LAD603 in healthy adult participants in both Part 1 and 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LAD603
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 29 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is male or female aged between 18 and 65 years, inclusive, at the time of signing the informed consent.
- Participant is willing and able to understand and comply with study requirements
- Participant is willing to participate and have provided signed informed consent in accordance with institutional and regulatory guidelines, and authorization to use protected health information (Health Insurance Portability and Accountability Act [HIPAA]) prior to any study-related procedures being performed.
- Participant has a body mass index (BMI) of greater than or equal to (>=) 18.5 and less than or equal to (<=) 29.9 kilogram per meter square (kg/m^2) with a body weight of at least 60 kg.
- Participant is in good health as determined by medical history and has no clinically relevant abnormalities in the physical examination, vital signs, 12-lead ECG, and laboratory tests as determined by the Investigator.
- Participant is a female who is not pregnant (i.e., does not have a positive serum pregnancy test on Day -1]) or breastfeeding, and who is either not a WOCBP or is a WOCBP who agrees to follow the contraceptive guidance for at least 28 days or 1 menstrual period (whichever is longer) prior to Day -1 until 30 days after the last dose of investigational medical product (IMP) and to refrain from egg donation/collection until at least 60 days after the last dose of IMP OR Participant is a male who either had a vasectomy at least 90 days prior to Screening (with appropriate post vasectomy documentation of absence of sperm in the ejaculate) or who agrees to use contraception from the Day 1 visit until 30 days after the last dose of IMP and to refrain from sperm donation during this period, or is a vasectomized male who agrees to use a condom from the Day 1 visit until 30 days after the last dose of IMP.
Who cannot join
- Participant has a history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (including drug allergies, any active seizure disorder requiring therapy with antiepileptic drugs, active peptic ulcer disease, gastrointestinal bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea, but excluding mild seasonal allergies or stable, well-controlled thyroiditis), a history of organ transplant, or is at increased risk for capillary leak syndrome.
- Participant has had major surgery (requiring general anesthesia) within 3 months prior to Baseline (Day -1).
- Participant has a history of cancer or lymphoproliferative disease within the previous 5 years, other than resected cutaneous basal cell, squamous cell carcinoma or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Participant has a clinically significant ECG abnormality at Screening or Baseline (Day -1), including, but not limited to, the following:
- An abnormal PR interval (>=220 millisecond [msec] or <=100 msec)
- QTc prolongation (corrected QT interval by Fredericia's formula [QTcF] >=450 msec)
Show all 29Show fewer
- Participant has a mean heart rate (HR) at Screening or Baseline (Day -1) that is <=45 beats per minute (bpm) or >100 bpm
- Participant has systolic blood pressure <90 millimeter of mercury (mmHg) or >140 mmHg or diastolic blood pressure <50 mmHg or >90 mmHg at Screening or Baseline (Day -1)
- Participant with active chronic or acute infection including skin infection requiring treatment with systemic antimicrobials, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before Baseline (Day -1), or skin infections within 4 weeks prior to Baseline (Day -1), or fever >38°C of unknown etiology within 1 week prior to Baseline (Day -1).
- Participant has known hypersensitivity to any of the formulation excipients of the IMP or previous severe adverse reaction to subcutaneous medication.
- Participant has hypersensitivity or reaction to a prior antibody-based biologic therapy (regardless of indication) that was clinically significant, as per judgment of Investigator.
- Participant has positive results for hepatitis B surface antigen (HBsAg), antihepatitis B core antigen (anti-HBcAg), antibody to the hepatitis C virus (anti-HCV), or antibody to the human immunodeficiency virus (HIV-1/2). A history of hepatitis B vaccination without history of hepatitis B is allowed.
- Participant has a positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) prior to dosing at Baseline (Day -1).
- Participant has received any type of live or attenuated vaccinations within 28 days prior to Baseline (Day -1), or is planning to receive any such vaccine during the study (inactive vaccines are allowed) or has received a SARS-CoV-2 vaccine within 14 days prior to Baseline (Day -1). Seasonal influenza and H1N1 vaccinations are permitted if the inactivated vaccine formulation is administered.
- Participant with history of active or latent tuberculosis, or recent close contact with an individual with active tuberculosis, or is positive at the Screening visit by tuberculin blood test (eg, QuantiFERON).
- Participant with congenital or acquired immunosuppressive condition that would put participant at risk during the study.
- Participant with a history (within 6 months prior to Screening visit) of drug and/or alcohol abuse that may prevent trial compliance based on Investigator judgment.
- Females who are pregnant or breast-feeding or seeking to become pregnant during the study or for approximately 30 days after the last dose of IMP.
- Participant is a current smoker and is unable to restrain from smoking during the study.
- Participant has a positive test for drugs of abuse and/or alcohol.
- Participant has received any investigational drug in any clinical study within 30 days (or at least 5 half-lives, whichever is longer) prior to Baseline (Day -1) or is on extended follow-up from such a clinical study
- Participant has taken any medications, including over-the-counter (OTC) medications, within 14 days (or at least 5 half-lives, whichever is longer) before Baseline (Day -1) (note that hormonal contraceptives are allowed, and acetaminophen is permitted at doses <=2 gram per day (g/day) up to 48 hours prior to each study visit), unless in the opinion of the Investigator and CRO Medical Monitor the medication will not interfere with the study procedures or compromise participant safety. Participants taking drugs that are substrates of cytochrome P450 or have a narrow therapeutic index are excluded from participating in this study.
- Participants with ANY of the following abnormalities in clinical laboratory tests at Screening or, if applicable, Day -1, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
- Neutrophil or lymphocyte counts below the lower limit of the normal range.
- Eosinophil count above the normal range (i.e., >500/mm^3).
- Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) calculation <=90 mL/min/1.73 m^2 at Screening.
- Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) or alkaline phosphatase (ALP) > Upper limit of the normal range (ULN).
- Total bilirubin >ULN
- Other clinically significant abnormalities of laboratory assessments, as judged by the Investigator and/or Sponsor Medical Monitor that could affect the safety of the participant, or the interpretation of the data from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, 2-part, Single-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of LAD603 in Healthy Adult Subjects
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple ascending doses of LAD603 in healthy adult participants in both Part 1 and 2.
Read the detailed description
This is a 2-part study. Part 1 will comprise up to 8 cohorts of healthy adult participants and investigate single ascending doses of LAD603. Part 2 will comprise up to 4 cohorts of healthy adult subjects and will investigate multiple ascending doses of LAD603. Each ascending dose level will be investigated by a sequential cohort, with dose escalation based on satisfactory safety, tolerability, PK, and pharmacodynamics (PD) (biomarker) data from the previous cohort(s). Dose levels evaluated in Part 2 of this study will not exceed dose levels that were safe and well tolerated in the single-dose study, and may be changed, depending on emerging safety and tolerability, PK, and PD (biomarker) data.
Each participant will participate for about 8 weeks in Part 1 and for about 14 weeks in Part 2 of the study.
- Conditions
- Healthy Volunteers
- Being tested
- LAD603, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAD603Drug
LAD603 SC injection.
PlaceboOther
Matching placebo SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: (LAD603) Cohort 1 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: (LAD603) Cohort 2 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: (LAD603) Cohort 3 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: (LAD603) Cohort 4 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: (LAD603) Cohort 5 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: (LAD603) Cohort 6 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: (LAD603) Cohort 7 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: (LAD603) Cohort 8 | Experimental | Participants will receive single ascending dose of LAD603 SC injection on Day 1. Receives: Drug: LAD603 |
| Part 1: Placebo | Placebo comparator | Participants will receive single ascending dose of matching placebo SC injection on Day 1. Receives: Other: Placebo |
| Part 2: (LAD603) Cohort A | Experimental | Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. Receives: Drug: LAD603 |
| Part 2: (LAD603) Cohort B | Experimental | Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. Receives: Drug: LAD603 |
| Part 2: (LAD603) Cohort C | Experimental | Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. Receives: Drug: LAD603 |
| Part 2: (LAD603) Cohort D | Experimental | Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. Receives: Drug: LAD603 |
| Part 2: Placebo | Placebo comparator | Participants will receive multiple ascending dose of matching placebo SC injection on Days 1, 8 15, and 22. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Adverse Events (AEs) and Severity of AEs
Measured: Baseline up to Day 31
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
Measured: Baseline up to Day 31
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Electrocardiograms (ECGs) Parameters
Measured: Baseline up to Day 31
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Measured: Baseline up to Day 31
Part 2: Number of Participants with AEs and Severity of AEs
Measured: Baseline up to Day 64
Part 2: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
Measured: Baseline up to Day 64
Part 2: Number of Participants with Clinically Significant Changes from Baseline in ECGs Parameters
Measured: Baseline up to Day 64
Part 2: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Measured: Baseline up to Day 64
Secondary outcomes (22)
Part 1: Maximum Serum Concentration (Cmax) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Minimum Serum Concentration (Cmin) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Time to Reach Maximum Serum Concentration (Tmax) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to Time of the Last Concentration (AUC0-t) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to infinity (AUC0-inf) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to 1 Week After Investigational Medicinal Product (IMP) Administration (AUC0-1w) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Elimination Half-life (t½) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Smallest Terminal Elimination Rate Constant (λz) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Apparent Total Serum Clearance (CL/F) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Mean Residence Time (MRT) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτ) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 1)
Part 2: Maximum Serum Concentration (Cmax) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 1)
Part 2: Time to Reach Maximum Serum Concentration (Tmax) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτ) at Steady State of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Average Steady State Serum Drug Concentration (Cav,ss)
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Elimination Half-life (t½) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Smallest Terminal Elimination Rate Constant (λz) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Accumulation Ratios (RA) at Steady State Based on AUCτ (RA[AUC]) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Accumulation Ratios (RA) at Steady State Based on Cmax (RA[Cmax]) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Serum Concentration Observed at the Last Planned Sampling Timepoint Prior to Dosing (Ctrough; RA[Ctrough]) of LAD603
Measured: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Serum Concentration Observed at the Last Planned Sampling Timepoint Prior to Dosing (Ctrough) of LAD603
Measured: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: 24 and 36 hours (Day 2), 48 hours (Day 3), 96 hours (Day 5), 168 hours (Day 8); Pre-dose (Day 15); Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start5 Dec 2023
- Primary completion11 May 2025
- Study completion29 May 2025
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
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200597
- Sponsor's protocol ID
- M-00223-01
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, 2-part, Single-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of LAD603 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06200597
- Acronym / sponsor ID
- M-00223-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 11 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 11 Jan 2024 (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 purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple ascending doses of LAD603 in healthy adult participants in both Part 1 and 2.
Detailed description
This is a 2-part study. Part 1 will comprise up to 8 cohorts of healthy adult participants and investigate single ascending doses of LAD603. Part 2 will comprise up to 4 cohorts of healthy adult subjects and will investigate multiple ascending doses of LAD603. Each ascending dose level will be investigated by a sequential cohort, with dose escalation based on satisfactory safety, tolerability, PK, and pharmacodynamics (PD) (biomarker) data from the previous cohort(s). Dose levels evaluated in Part 2 of this study will not exceed dose levels that were safe and well tolerated in the single-dose study, and may be changed, depending on emerging safety and tolerability, PK, and PD (biomarker) data.
Each participant will participate for about 8 weeks in Part 1 and for about 14 weeks in Part 2 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1: (LAD603) Cohort 1 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: (LAD603) Cohort 2 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: (LAD603) Cohort 3 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: (LAD603) Cohort 4 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: (LAD603) Cohort 5 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: (LAD603) Cohort 6 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: (LAD603) Cohort 7 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: (LAD603) Cohort 8 | Experimental | Drug: LAD603Participants will receive single ascending dose of LAD603 SC injection on Day 1. |
| Part 1: Placebo | Placebo comparator | Other: PlaceboParticipants will receive single ascending dose of matching placebo SC injection on Day 1. |
| Part 2: (LAD603) Cohort A | Experimental | Drug: LAD603Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. |
| Part 2: (LAD603) Cohort B | Experimental | Drug: LAD603Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. |
| Part 2: (LAD603) Cohort C | Experimental | Drug: LAD603Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. |
| Part 2: (LAD603) Cohort D | Experimental | Drug: LAD603Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22. |
| Part 2: Placebo | Placebo comparator | Other: PlaceboParticipants will receive multiple ascending dose of matching placebo SC injection on Days 1, 8 15, and 22. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is male or female aged between 18 and 65 years, inclusive, at the time of signing the informed consent.
- Participant is willing and able to understand and comply with study requirements
- Participant is willing to participate and have provided signed informed consent in accordance with institutional and regulatory guidelines, and authorization to use protected health information (Health Insurance Portability and Accountability Act [HIPAA]) prior to any study-related procedures being performed.
- Participant has a body mass index (BMI) of greater than or equal to (>=) 18.5 and less than or equal to (<=) 29.9 kilogram per meter square (kg/m^2) with a body weight of at least 60 kg.
- Participant is in good health as determined by medical history and has no clinically relevant abnormalities in the physical examination, vital signs, 12-lead ECG, and laboratory tests as determined by the Investigator.
Key exclusion criteria (29 listed)
- Participant has a history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (including drug allergies, any active seizure disorder requiring therapy with antiepileptic drugs, active peptic ulcer disease, gastrointestinal bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea, but excluding mild seasonal allergies or stable, well-controlled thyroiditis), a history of organ transplant, or is at increased risk for capillary leak syndrome.
- Participant has had major surgery (requiring general anesthesia) within 3 months prior to Baseline (Day -1).
- Participant has a history of cancer or lymphoproliferative disease within the previous 5 years, other than resected cutaneous basal cell, squamous cell carcinoma or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
- Participant has a clinically significant ECG abnormality at Screening or Baseline (Day -1), including, but not limited to, the following:
- Participant has a mean heart rate (HR) at Screening or Baseline (Day -1) that is <=45 beats per minute (bpm) or >100 bpm
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 |
|---|---|---|
| LAD603LAD603 SC injection. | Drug | Part 1: (LAD603) Cohort 1, Part 1: (LAD603) Cohort 2, Part 1: (LAD603) Cohort 3, Part 1: (LAD603) Cohort 4, Part 1: (LAD603) Cohort 5, Part 1: (LAD603) Cohort 6, Part 1: (LAD603) Cohort 7, Part 1: (LAD603) Cohort 8, Part 2: (LAD603) Cohort A, Part 2: (LAD603) Cohort B, Part 2: (LAD603) Cohort C, Part 2: (LAD603) Cohort D |
| PlaceboMatching placebo SC injection. | Other | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Part 1: Number of Participants with Adverse Events (AEs) and Severity of AEs
Time frame: Baseline up to Day 31
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
Time frame: Baseline up to Day 31
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Electrocardiograms (ECGs) Parameters
Time frame: Baseline up to Day 31
Part 1: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Time frame: Baseline up to Day 31
Part 2: Number of Participants with AEs and Severity of AEs
Time frame: Baseline up to Day 64
Part 2: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter
Time frame: Baseline up to Day 64
Part 2: Number of Participants with Clinically Significant Changes from Baseline in ECGs Parameters
Time frame: Baseline up to Day 64
Part 2: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters
Time frame: Baseline up to Day 64
22 secondary outcomes
Part 1: Maximum Serum Concentration (Cmax) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Minimum Serum Concentration (Cmin) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Time to Reach Maximum Serum Concentration (Tmax) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to Time of the Last Concentration (AUC0-t) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to infinity (AUC0-inf) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to 1 Week After Investigational Medicinal Product (IMP) Administration (AUC0-1w) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Elimination Half-life (t½) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Smallest Terminal Elimination Rate Constant (λz) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Apparent Total Serum Clearance (CL/F) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Mean Residence Time (MRT) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 1: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: at 24 and 36 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), 120 hours (Day 6), 168 hours (Day 8), 240 hours (Day 11); 336 hours (Day 15), 504 hours (Day 22), 672 hours (Day 29)
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτ) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 1)
Part 2: Maximum Serum Concentration (Cmax) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 1)
Part 2: Time to Reach Maximum Serum Concentration (Tmax) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτ) at Steady State of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Average Steady State Serum Drug Concentration (Cav,ss)
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Elimination Half-life (t½) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Smallest Terminal Elimination Rate Constant (λz) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Accumulation Ratios (RA) at Steady State Based on AUCτ (RA[AUC]) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Accumulation Ratios (RA) at Steady State Based on Cmax (RA[Cmax]) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Serum Concentration Observed at the Last Planned Sampling Timepoint Prior to Dosing (Ctrough; RA[Ctrough]) of LAD603
Time frame: Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Part 2: Serum Concentration Observed at the Last Planned Sampling Timepoint Prior to Dosing (Ctrough) of LAD603
Time frame: Pre-dose, 2, 6, 12 hours (Day 1); Post-dose: 24 and 36 hours (Day 2), 48 hours (Day 3), 96 hours (Day 5), 168 hours (Day 8); Pre-dose (Day 15); Pre-dose, 2, 6, and 12 hours post-dose (Day 22)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 LAD603 in people with Healthy Volunteers, run by Almirall, S.A. at 1 site in United States.
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 29 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: finished, as of the sponsor's last update on 17 Dec 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants with Adverse Events (AEs) and Severity of AEs (time frame: Baseline up to Day 31). The study lists 8 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 17 Dec 2025.