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Part 1: LAD191 (Cohort 1) 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose at days 1, 8, 15, 22, 29, and 36; at 4 hours and 48 hours post-dose on days 1, 36, 40, 43, 50, 64, 85 and 92
Awards & highlights

Summary

The main purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity of LAD191 in healthy adults and in adults with an autoimmune disease.

Eligible Conditions
  • Autoimmune Diseases
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose at days 1, 8, 15, 22, 29, and 36; at 4 hours, 24 hours and 48 hours post-dose on days 1, 36, 40, 43, 50, 64, 85 and 92
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose at days 1, 8, 15, 22, 29, and 36; at 4 hours, 24 hours and 48 hours post-dose on days 1, 36, 40, 43, 50, 64, 85 and 92 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Number of Participants who have Dose-limiting Adverse Reactions
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
+9 more
Secondary study objectives
Part 1: Apparent Total Serum Clearance (CL/F) of LAD191
Part 1: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191
Part 1: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191
+38 more

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).

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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.
1,252 Previous Clinical Trials
504,307 Total Patients Enrolled
2 Trials studying Autoimmune Diseases
144 Patients Enrolled for Autoimmune Diseases
~23 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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