What is the mechanism of action of this treatment?

The mechanisms of action for common treatments in healthy subjects often involve pharmacokinetics and immunogenicity. Pharmacokinetics studies how a drug is absorbed, distributed, metabolized, and excreted, which helps determine the appropriate dosage and frequency to achieve optimal therapeutic levels without causing toxicity. Immunogenicity assesses the potential of a drug to trigger an immune response, which is important for identifying and mitigating adverse effects. These mechanisms are crucial for ensuring the safety and efficacy of new treatments, such as LAD603, by predicting their behavior in the body and their potential impact on the immune system.

What side effects are associated with this type of intervention?

Common treatments involving pharmacokinetics and immunogenicity, such as biologics and immunomodulatory drugs, often have side effects that include fatigue, infusion-related reactions, and nausea. More severe side effects can include increased susceptibility to infections, hyperglycemia, bone loss, and neuropsychiatric effects. These side effects are generally consistent across various treatments studied for their safety and tolerability in healthy subjects.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects often focus on evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of new drugs. While specific drugs similar to LAD603 are not detailed, the general approach involves conducting single and multiple ascending dose studies to assess these parameters. Such studies are crucial for understanding how a drug behaves in the body and its potential immune response, which are essential steps before considering broader clinical applications.

What other types of research exist?

Promising alternatives to LAD603 include AL-683, which has shown a 37-fold improvement in half-life (T1/2) and a 33-fold improvement in area under the curve (AUC) compared to unglycosylated mouse IFN-α-1, suggesting potential for bimonthly or monthly dosing. Additionally, SLN360, a short interfering RNA targeting lipoprotein(a), has demonstrated dose-dependent lowering of plasma Lp(a) concentrations and good tolerability, making it a viable candidate for further study.

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Monoclonal Antibodies

LAD603 for Healthy Adults

Phase 1

Recruiting

Research Sponsored by Almirall, S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is male or female aged between 18 and 65 years, inclusive, at the time of signing the informed consent

Participant has a body mass index (BMI) of >= 18.5 and <= 29.9 kg/m^2 with a body weight of at least 60 kg

Must not have

Participant has a history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease, a history of organ transplant, or is at increased risk for capillary leak syndrome

Participant has abnormal PR interval, QTc prolongation, mean heart rate <=45 bpm or >100 bpm, or abnormal blood pressure at Screening or Baseline (Day -1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new drug called LAD603 in healthy adults to see if it is safe and how the body handles it. Researchers will give different doses to check for side effects and how the drug is processed.

Who is the study for?

This trial is for healthy adults who can participate in a study to assess the safety and effects of a new medication, LAD603. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.

What is being tested?

The study is testing LAD603 against a placebo to see how safe it is and how the body responds to different doses. It's divided into two parts: one where subjects receive a single dose, and another with multiple doses over time.

What are the potential side effects?

Since this information isn't provided directly, potential side effects generally include reactions at the injection site, headaches, nausea or other symptoms that will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My BMI is between 18.5 and 29.9, and I weigh at least 60 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant medical history or condition that affects my organs.

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My heart rate or blood pressure readings were abnormal during my initial check-up.

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I have not had any live vaccines in the last 28 days or COVID-19 vaccine in the last 14 days.

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I have a history of tuberculosis or have been in close contact with someone who has active tuberculosis.

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I have a condition that weakens my immune system, making me more vulnerable.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I have not had major surgery in the last 3 months.

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I have not had any serious infections or fevers needing strong medication in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

14Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: (LAD603) Cohort DExperimental Treatment1 Intervention

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Group II: Part 2: (LAD603) Cohort CExperimental Treatment1 Intervention

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Group III: Part 2: (LAD603) Cohort BExperimental Treatment1 Intervention

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Group IV: Part 2: (LAD603) Cohort AExperimental Treatment1 Intervention

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Group V: Part 1: (LAD603) Cohort 8Experimental Treatment1 Intervention