Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease
NCT Number: NCT06488209
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers|Autoimmune Disease
Interventions: DRUG: LAD191|OTHER: Placebo
Sponsor: Almirall, S.A.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2022-07-29
Completion Date: 2024-09
Locations: Doral Medical Research, Miami, Florida, 33165, United States|Jennifer Parish, MD, Philadelphia, Pennsylvania, 19103, United States|ICON Early Phase Services, LLC, San Antonio, Texas, 78209, United States

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.

Primary Outcome Measures: Part 1: Number of Participants with Adverse Events (AEs) and Severity of AEs, Baseline up to Day 73|Part 1: Number of Participants who have Dose-limiting Adverse Reactions, Baseline up to Day 73|Part 1: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter, Baseline up to Day 73|Part 1: Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Findings, Baseline up to Day 73|Part 1: Number of Participants with Clinically Significant Changes from Baseline in Electrocardiograms (ECGs) Parameters, Baseline up to Day 73|Part 1: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters, Baseline up to Day 73|Part 2 and 3: Number of Participants with Adverse Events (AEs) and Severity of AEs, Baseline up to Day 94|Part 2 and 3: Number of Participants who have Dose-limiting Adverse Reactions, Baseline up to Day 94|Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter, Baseline up to Day 94|Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Physical Examination Findings, Baseline up to Day 94|Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in ECGs Parameters, Baseline up to Day 94|Part 2 and 3: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters, Baseline up to Day 94
Secondary Outcome Measures: Part 1: Maximum Serum Concentration (Cmax) of LAD191, Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71|Part 1: Time to Reach Maximum Serum Concentration (Tmax) of LAD191, Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71|Part 1: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191, Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71|Part 1: Area Under the Serum Concentration-time Curve from Zero to infinity (AUC0-inf) of LAD191, Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71|Part 1: Elimination Half-life (t½) of LAD191, Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71|Part 1: Apparent Total Serum Clearance (CL/F) of LAD191, Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71|Part 1: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191, Pre-dose, 4 hours and 8 hours post-dose on Days 1, 2, 3, 4, 6, 8, 15, 22, 29, 43, 57 and 71|Part 1: Number of Participants with Positive Anti-drug Antibodies (ADA) and Titer of ADA of LAD191, Pre-dose on Day 1; 24 hours post-dose on Days 15; 48 hours post-dose on Days 43 and 71|Part 2: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191, 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|Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) of LAD191, 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|Part 2: Maximum Serum Concentration (Cmax) of LAD191, 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|Part 2: Time to Reach Maximum Serum Concentration (Tmax) of LAD191, 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|Part 2: Minimum Serum Concentrations (Cmin) of LAD191, 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|Part 2: Time to Cmin (tmin) of LAD191, 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|Part 2: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) at Steady State of LAD191, 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|Part 2: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) at Steady State of LAD191, 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|Part 2: Maximum Serum Concentration (Cmax) at Steady State of LAD191, 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|Part 2: Time to Reach Maximum Serum Concentration (Tmax) at Steady State of LAD191, 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|Part 2: Minimum Serum Concentrations (Cmin) at Steady State of LAD191, 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|Part 2: Time to Cmin (tmin) at Steady State of LAD191, 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|Part 2: Apparent Total Serum Clearance (CL/F) of LAD191, 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|Part 2: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191, 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|Part 2: Elimination Half-life (t½) of LAD191, 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|Part 2: Accumulation Ratios Based on AUC (R[AUC]) of LAD191, 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|Part 2 and 3: Number of Participants with Positive ADA and Titer of ADA of LAD191, Pre-dose on Days 1, 15, and 29; 4 hours post-dose on Days 43; 48 hours post-dose on 64 and 92|Part 3: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) of LAD191, 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|Part 3: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) of LAD191, 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|Part 3: Maximum Serum Concentration (Cmax) of LAD191, 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|Part 3: Time to Reach Maximum Serum Concentration (Tmax) of LAD191, 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|Part 3: Minimum Serum Concentrations (Cmin) of LAD191, 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|Part 3: Time to Cmin (tmin) of LAD191, 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|Part 3: Area Under the Serum Concentration-time Curve from Zero to Time of the Last Quantifiable Concentration (AUC0-t) at Steady State of LAD191, 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|Part 3: Area Under the Concentration-time Curve within a Dosing Interval (AUCτau) at Steady State of LAD191, 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|Part 3: Maximum Serum Concentration (Cmax) at Steady State of LAD191, 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|Part 3: Time to Reach Maximum Serum Concentration (Tmax) at Steady State of LAD191, 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|Part 3: Minimum Serum Concentrations (Cmin) at Steady State of LAD191, 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|Part 3: Time to Cmin (tmin) at Steady State of LAD191, 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|Part 3: Apparent Total Serum Clearance (CL/F) of LAD191, 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|Part 3: Apparent Volume of Distribution Associated with the Terminal Phase (Vd/F) of LAD191, 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|Part 3: Elimination Half-life (t½) of LAD191, 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|Part 3: Accumulation Ratios Based on AUC (R[AUC]) of LAD191, 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