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Monoclonal Antibodies
LAD191 for Autoimmune Diseases
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
1. Participant provides written informed consent prior to any protocol related procedures, including screening evaluations. Participant must be able to understand the consent form and instructions and to provide consent directly; no guardian/legal representative or caregiver may provide consent for the participant.
2. Male or female, greater than or equal to (\>=)18 and less than or equal to (\<=) 65 years of age, with a body mass index (BMI) within the range of 18.5 to 29.9 kilogram per square meter (kg/m\^2) (inclusive) and body weight of \>=50 kilograms (kg).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
"This trial aims to test the safety, effectiveness, and how the body processes LAD191 in both healthy adults and adults with an autoimmune disease."
Who is the study for?
This trial is for adults aged 18-65 with a BMI of 18.5 to 34.9 and weight over 50 kg, who are healthy or have an autoimmune disease. Participants must not be pregnant, agree to use effective contraception, and pass medical assessments.
What is being tested?
The study tests LAD191's safety and effects on the body in both healthy individuals and those with an autoimmune condition compared to a placebo (a substance with no active drug).
What are the potential side effects?
Potential side effects aren't specified but generally may include reactions at the injection site, flu-like symptoms, fatigue, headaches or other immune-related responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have given my written consent to participate and understand the study details myself.
Select...
I am between 18 and 65 years old, with a BMI of 18.5-29.9 and weigh at least 50kg.
Select...
I am between 18 and 65 years old, with a BMI of 18.5-34.9 and weigh at least 50 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
12Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3: LAD191 (Cohort 9)Experimental Treatment1 Intervention
Participants will receive repeat doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.
Group II: Part 2: LAD191 (Cohort 8)Experimental Treatment1 Intervention
Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.
Group III: Part 2: LAD191 (Cohort 7)Experimental Treatment1 Intervention
Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.
Group IV: Part 2: LAD191 (Cohort 6)Experimental Treatment1 Intervention
Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.
Group V: Part 1: LAD191 (Cohort 5)Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD191 SC injection on Day 1.
Group VI: Part 1: LAD191 (Cohort 4)Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD191 SC injection on Day 1.
Group VII: Part 1: LAD191 (Cohort 3)Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD191 SC injection on Day 1.
Group VIII: Part 1: LAD191 (Cohort 2)Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD191 SC injection on Day 1.
Group IX: Part 1: LAD191 (Cohort 1)Experimental Treatment1 Intervention
Participants will receive single ascending dose of LAD191 subcutaneous (SC) injection on Day 1.
Group X: Part 1: PlaceboPlacebo Group1 Intervention
Participants will receive single dose of matching placebo SC injection on Day 1 (Cohort 1 to Cohort 5).
Group XI: Part 2: PlaceboPlacebo Group1 Intervention
Participants will receive multiple doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 6 to Cohort 8).
Group XII: Part 3: PlaceboPlacebo Group1 Intervention
Participants will receive repeat doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 9).
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Almirall, S.A.Lead Sponsor
61 Previous Clinical Trials
18,174 Total Patients Enrolled
Study DirectorStudy DirectorAlmirall, S.A.
1,290 Previous Clinical Trials
500,646 Total Patients Enrolled