Evaluating LAD603 in healthy adults

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

This study is testing a new drug called LAD603 in healthy adults to see if it's safe and how the body reacts to it when given in different doses.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Almirall, S.A. (Industry-sponsored)
• Locations: 1 site (Lenexa, Kansas)
• Trial ID: NCT06200597 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, pharmacokinetics, and immunogenicity of LAD603 through both single and multiple ascending doses in healthy adult participants. It consists of two parts: the first part involves up to 8 cohorts receiving single ascending doses, while the second part includes up to 4 cohorts receiving multiple ascending doses. Dose escalation will depend on the safety and tolerability data from previous cohorts, ensuring that only safe dose levels are tested. Each participant will be involved for approximately 8 weeks in Part 1 and 14 weeks in Part 2.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18.5 and 29.9.

Not a fit: Patients with significant health issues or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and dosing of LAD603, potentially leading to its use in future treatments.

How similar studies have performed: Other studies evaluating similar ascending dose methodologies have shown success in establishing safety and dosing parameters.

Eligibility criteria

Inclusion Criteria:

1. Participant is male or female aged between 18 and 65 years, inclusive, at the time of signing the informed consent.
2. Participant is willing and able to understand and comply with study requirements
3. 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.
4. 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.
5. 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.
6. 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.

Exclusion Criteria:

1. 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.
2. Participant has had major surgery (requiring general anesthesia) within 3 months prior to Baseline (Day -1).
3. 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.
4. 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)
5. Participant has a mean heart rate (HR) at Screening or Baseline (Day -1) that is \<=45 beats per minute (bpm) or \>100 bpm
6. 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)
7. 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).
8. Participant has known hypersensitivity to any of the formulation excipients of the IMP or previous severe adverse reaction to subcutaneous medication.
9. Participant has hypersensitivity or reaction to a prior antibody-based biologic therapy (regardless of indication) that was clinically significant, as per judgment of Investigator.
10. 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.
11. Participant has a positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) prior to dosing at Baseline (Day -1).
12. 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.
13. 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).
14. Participant with congenital or acquired immunosuppressive condition that would put participant at risk during the study.
15. 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.
16. 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.
17. Participant is a current smoker and is unable to restrain from smoking during the study.
18. Participant has a positive test for drugs of abuse and/or alcohol.
19. 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
20. 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.
21. 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.

Where this trial is running

Lenexa, Kansas

• ICON Phase 1 unit Lenexa — Lenexa, Kansas, United States (Recruiting)

Study contacts

• Study coordinator: Davide Carluccio

Conditions Healthy Volunteers