Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease

NCT06488209 | Completed Phase 1 FDA Drug

• 1 other identifier: M-27134-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Healthy Volunteers; Autoimmune Disease

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (41)

• 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

Study Arms (12)

Part 1: LAD191 (Cohort 1)

EXPERIMENTAL

Participants will receive single ascending dose of LAD191 subcutaneous (SC) injection on Day 1.

Drug: LAD191

Part 1: LAD191 (Cohort 2)

EXPERIMENTAL

Participants will receive single ascending dose of LAD191 SC injection on Day 1.

Drug: LAD191

Part 1: LAD191 (Cohort 3)

EXPERIMENTAL

Participants will receive single ascending dose of LAD191 SC injection on Day 1.

Drug: LAD191

Part 1: LAD191 (Cohort 4)

EXPERIMENTAL

Participants will receive single ascending dose of LAD191 SC injection on Day 1.

Drug: LAD191

Part 1: LAD191 (Cohort 5)

EXPERIMENTAL

Participants will receive single ascending dose of LAD191 SC injection on Day 1.

Drug: LAD191

Part 1: Placebo

PLACEBO COMPARATOR

Participants will receive single dose of matching placebo SC injection on Day 1 (Cohort 1 to Cohort 5).

Other: Placebo

Part 2: LAD191 (Cohort 6)

EXPERIMENTAL

Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.

Drug: LAD191

Part 2: LAD191 (Cohort 7)

EXPERIMENTAL

Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.

Drug: LAD191

Part 2: LAD191 (Cohort 8)

EXPERIMENTAL

Participants will receive multiple ascending doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.

Drug: LAD191

Part 2: Placebo

PLACEBO COMPARATOR

Participants will receive multiple doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 6 to Cohort 8).

Other: Placebo

Part 3: LAD191 (Cohort 9)

EXPERIMENTAL

Participants will receive repeat doses of LAD191 SC injection on Days 1, 8, 15, 22, 29 and 36.

Drug: LAD191

Part 3: Placebo

PLACEBO COMPARATOR

Participants will receive repeat doses of matching placebo SC injection on Days 1, 8, 15, 22, 29 and 36 (Cohort 9).

Other: Placebo

Interventions

LAD191 DRUG

LAD191 SC injection.

Part 1: LAD191 (Cohort 1); Part 1: LAD191 (Cohort 2); Part 1: LAD191 (Cohort 3); Part 1: LAD191 (Cohort 4); Part 1: LAD191 (Cohort 5); Part 2: LAD191 (Cohort 6); Part 2: LAD191 (Cohort 7); Part 2: LAD191 (Cohort 8); Part 3: LAD191 (Cohort 9)

Placebo OTHER

Matching placebo SC injection.

Part 1: Placebo; Part 2: Placebo; Part 3: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (Applicable to Both Healthy and an Autoimmune Disease Participants Unless Indicated Otherwise)
• 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.
• 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).
• Participant is healthy, in the clinical judgement of the Investigator, based medical history, physical examination, vital signs, ECG, and laboratory investigations (i.e., has clinical laboratory tests that are within the reference ranges or are clinically acceptable per Investigator judgment).
• Participant has a seated systolic blood pressure (SBP) \>=90 mm Hg and \<=140 mm Hg or a seated diastolic BP (DBP) \>=50 mm Hg or \<=90 mm Hg.
• Participant is willing and able to understand and comply with all aspects of the protocol.
• Participant must agree to the following requirements during the study:
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result within 7 days prior to first dosing plus a negative urine pregnancy test pre-dose on Day 1 and must be willing to use a highly effective form of contraception (ICH E8 Guideline, 1997; (ICH M3 \[R2\] Guidance, 2009; (FDA M3 \[R2\] Guidance, 2010) for the duration of the study and for at least 3 months after the last dose of study medication. Methods like periodic abstinence, post-ovulation procedures and withdrawal are not considered adequate.
• Males with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception during the study. Male participants must continue to use contraception (condoms plus a second effective method) for 165 days following administration of the study drug.
• Male participants must agree not to donate sperm during the study and for 165 days following administration of the study drug.
• Participants with an Autoimmune Disease (Cohort 9 Only):
• Male or female, \>=18 to \<=65 years of age, with a BMI within the range 18.5 to 34.9 kg/ m\^2, and body weight of \>=50 kg.
• Current diagnosis of an autoimmune disease by the Investigator and with signs and symptoms consistent with an autoimmune disease for at least 3 months prior to Day -1 (baseline).

You may not qualify if:

• (Applicable to Both Healthy and an Autoimmune Disease Participants Unless Indicated Otherwise)
• Participant has received treatment with LAD191 previously.
• Known hypersensitivity to LAD191 or any of its excipients.
• Hypersensitivity or reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
• History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, inflammatory, or allergic disease (including drug allergies, any active seizure disorder requiring therapy with antiepileptic drugs, active peptic ulcer disease, gastrointestinal bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea, but excluding mild seasonal allergies or stable, well-controlled thyroiditis). Note that participants with thyroid hormone deficiency, hypertension, hyperlipidemia, or diabetes mellitus may be included in Part 3 of the study.
• Active chronic or acute infection requiring treatment with systemic antimicrobials, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day -1, or superficial skin infections within 4 weeks prior to Day -1, or fever \> 38°C during within 1 week before Day -1.
• A positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) on Day -1, or the second negative test after a previous SARS CoV-2 infection was \<=14 days before Day -1, or the participant's SARS CoV-2-associated symptoms resolved \<=14 days before Day -1.
• Presence of skin comorbidities that may interfere with study assessments, in the opinion of the Investigator.
• Participant has current tuberculosis (TB) or any history of active or latent TB, regardless of prior treatment.
• History of malignancy, regardless of outcome.
• Participant has any condition that, in the opinion of the Investigator, would interfere with the PK evaluation of LAD191 or participant safety or the interpretation of study results
• Clinically significant ECG abnormality, including, but not limited to, the following:
• An abnormal PR interval (\>=220 msec or \<=100 msec).
• QTc prolongation (corrected QT interval by Fredericia's formula \[QTcF\] \>=450 msec).
• Mean heart rate \<=45 bpm or \>100 bpm.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (3)

Doral Medical Research

Miami, Florida, 33165, United States

Location

Jennifer Parish, MD

Philadelphia, Pennsylvania, 19103, United States

Location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Parts 1 and 2 of the study will be single-blind and Part 3 will be double-blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: July 29, 2022
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)