A Single and Multiple Ascending Dose Study of LAD603 in Healthy Subjects

NCT06200597 | Completed Phase 1 FDA Drug

• 1 other identifier: M-00223-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple ascending doses of LAD603 in healthy adult participants in both Part 1 and 2.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

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

  Baseline up to Day 31

• Part 1: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter

  Baseline up to Day 31

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

  Baseline up to Day 31

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

  Baseline up to Day 31

• Part 2: Number of Participants with AEs and Severity of AEs

  Baseline up to Day 64

• Part 2: Number of Participants with Clinically Significant Changes from Baseline in Vital Sign Parameter

  Baseline up to Day 64

• Part 2: Number of Participants with Clinically Significant Changes from Baseline in ECGs Parameters

  Baseline up to Day 64

• Part 2: Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters

  Baseline up to Day 64

Secondary Outcomes (22)

• Part 1: Maximum Serum Concentration (Cmax) of LAD603

  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)

• Part 1: Minimum Serum Concentration (Cmin) of LAD603

  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)

• Part 1: Time to Reach Maximum Serum Concentration (Tmax) of LAD603

  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)

• Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to Time of the Last Concentration (AUC0-t) of LAD603

  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)

• Part 1: Area Under the Serum Concentration-time Curve (AUC) from Zero to infinity (AUC0-inf) of LAD603

  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)

Study Arms (14)

Part 1: (LAD603) Cohort 1

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: (LAD603) Cohort 2

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: (LAD603) Cohort 3

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: (LAD603) Cohort 4

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: (LAD603) Cohort 5

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: (LAD603) Cohort 6

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: (LAD603) Cohort 7

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: (LAD603) Cohort 8

EXPERIMENTAL

Participants will receive single ascending dose of LAD603 SC injection on Day 1.

Drug: LAD603

Part 1: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Part 2: (LAD603) Cohort A

EXPERIMENTAL

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Drug: LAD603

Part 2: (LAD603) Cohort B

EXPERIMENTAL

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Drug: LAD603

Part 2: (LAD603) Cohort C

EXPERIMENTAL

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Drug: LAD603

Part 2: (LAD603) Cohort D

EXPERIMENTAL

Participants will receive multiple ascending dose of LAD603 SC injection on Days 1, 15, 18 and 22.

Drug: LAD603

Part 2: Placebo

PLACEBO COMPARATOR

Participants will receive multiple ascending dose of matching placebo SC injection on Days 1, 8 15, and 22.

Other: Placebo

Interventions

LAD603 DRUG

LAD603 SC injection.

Part 1: (LAD603) Cohort 1; Part 1: (LAD603) Cohort 2; Part 1: (LAD603) Cohort 3; Part 1: (LAD603) Cohort 4; Part 1: (LAD603) Cohort 5; Part 1: (LAD603) Cohort 6; Part 1: (LAD603) Cohort 7; Part 1: (LAD603) Cohort 8; Part 2: (LAD603) Cohort A; Part 2: (LAD603) Cohort B; Part 2: (LAD603) Cohort C; Part 2: (LAD603) Cohort D

Placebo OTHER

Matching placebo SC injection.

Part 1: Placebo; Part 2: 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:

• Participant is male or female aged between 18 and 65 years, inclusive, at the time of signing the informed consent.
• Participant is willing and able to understand and comply with study requirements
• Participant is willing to participate and have provided signed informed consent in accordance with institutional and regulatory guidelines, and authorization to use protected health information (Health Insurance Portability and Accountability Act \[HIPAA\]) prior to any study-related procedures being performed.
• Participant has a body mass index (BMI) of greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 29.9 kilogram per meter square (kg/m\^2) with a body weight of at least 60 kg.
• Participant is in good health as determined by medical history and has no clinically relevant abnormalities in the physical examination, vital signs, 12-lead ECG, and laboratory tests as determined by the Investigator.
• Participant is a female who is not pregnant (i.e., does not have a positive serum pregnancy test on Day -1\]) or breastfeeding, and who is either not a WOCBP or is a WOCBP who agrees to follow the contraceptive guidance for at least 28 days or 1 menstrual period (whichever is longer) prior to Day -1 until 30 days after the last dose of investigational medical product (IMP) and to refrain from egg donation/collection until at least 60 days after the last dose of IMP OR Participant is a male who either had a vasectomy at least 90 days prior to Screening (with appropriate post vasectomy documentation of absence of sperm in the ejaculate) or who agrees to use contraception from the Day 1 visit until 30 days after the last dose of IMP and to refrain from sperm donation during this period, or is a vasectomized male who agrees to use a condom from the Day 1 visit until 30 days after the last dose of IMP.

You may not qualify if:

• Participant has a 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), a history of organ transplant, or is at increased risk for capillary leak syndrome.
• Participant has had major surgery (requiring general anesthesia) within 3 months prior to Baseline (Day -1).
• Participant has a history of cancer or lymphoproliferative disease within the previous 5 years, other than resected cutaneous basal cell, squamous cell carcinoma or carcinoma in situ of the cervix that has been treated with no evidence of recurrence.
• Participant has a clinically significant ECG abnormality at Screening or Baseline (Day -1), including, but not limited to, the following:
• An abnormal PR interval (\>=220 millisecond \[msec\] or \<=100 msec)
• QTc prolongation (corrected QT interval by Fredericia's formula \[QTcF\] \>=450 msec)
• Participant has a mean heart rate (HR) at Screening or Baseline (Day -1) that is \<=45 beats per minute (bpm) or \>100 bpm
• Participant has systolic blood pressure \<90 millimeter of mercury (mmHg) or \>140 mmHg or diastolic blood pressure \<50 mmHg or \>90 mmHg at Screening or Baseline (Day -1)
• Participant with active chronic or acute infection including skin infection requiring treatment with systemic antimicrobials, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before Baseline (Day -1), or skin infections within 4 weeks prior to Baseline (Day -1), or fever \>38°C of unknown etiology within 1 week prior to Baseline (Day -1).
• Participant has known hypersensitivity to any of the formulation excipients of the IMP or previous severe adverse reaction to subcutaneous medication.
• Participant has hypersensitivity or reaction to a prior antibody-based biologic therapy (regardless of indication) that was clinically significant, as per judgment of Investigator.
• Participant has positive results for hepatitis B surface antigen (HBsAg), antihepatitis B core antigen (anti-HBcAg), antibody to the hepatitis C virus (anti-HCV), or antibody to the human immunodeficiency virus (HIV-1/2). A history of hepatitis B vaccination without history of hepatitis B is allowed.
• Participant has a positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) prior to dosing at Baseline (Day -1).
• Participant has received any type of live or attenuated vaccinations within 28 days prior to Baseline (Day -1), or is planning to receive any such vaccine during the study (inactive vaccines are allowed) or has received a SARS-CoV-2 vaccine within 14 days prior to Baseline (Day -1). Seasonal influenza and H1N1 vaccinations are permitted if the inactivated vaccine formulation is administered.
• Participant with history of active or latent tuberculosis, or recent close contact with an individual with active tuberculosis, or is positive at the Screening visit by tuberculin blood test (eg, QuantiFERON).

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

ICON Phase 1 unit Lenexa

Lenexa, Kansas, 66219, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 11, 2024
• Study Start: December 5, 2023
• Primary Completion: May 11, 2025
• Study Completion: May 29, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)