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Monoclonal Antibodies

Part 2: (LAD603) Cohort B for Healthy Subjects

Q: Can individuals who have reached adulthood, specifically those beyond 18 years of age, participate in this ongoing medical research?

Eligible individuals for this clinical trial must fall between the ages of 18 and 65. It is worth noting that there are a total of 56 trials specifically targeting participants under the age of 18, while as many as 373 trials focus on patients over the age of 65.

Q: Are patients currently being accepted to participate in this clinical trial?

Indeed, according to clinicaltrials.gov, this research investigation is currently seeking suitable candidates. The trial was initially listed on December 5th, 2023 and underwent its latest update on December 29th, 2023.

Q: What is the current number of participants being recruited for this medical study?

Indeed, the information available on clinicaltrials.gov confirms that this clinical trial is actively seeking eligible individuals. The trial was initially posted on December 5th, 2023 and last edited on December 29th, 2023. A total of 92 participants are needed from a single location.

Q: What is the level of safety observed in Part 1: (LAD603) Cohort 4 for individuals?

Our team at Power rates the safety of Part 1: (LAD603) Cohort 4 with a score of 1 on a scale from 1 to 3. This rating is based on it being a Phase 1 trial, where there is limited data available regarding both safety and efficacy.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Study Summary

This trial aims to determine if LAD603 is safe and well-tolerated at different doses in healthy adults. It will also examine how the drug is processed in the body and its effects on the

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of Participants with Adverse Events (AEs) and Severity of AEs

Part 1: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters

Part 1: Number of Participants with Clinically Significant Changes from Baseline in Electrocardiograms (ECGs) Parameters

+5 more

Secondary outcome measures

Part 1: Apparent Total Serum Clearance (CL/F) of LAD603

Part 1: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of LAD603

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

+19 more

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