First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts

NCT05576012 | Completed Phase 1 Results DMC

• 1 other identifier: LPM-116-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a multiple dose part in healthy subjects (Part 3). The study will collect information on pharmacokinetics, safety and tolerability.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (8)

• Safety and Tolerability: Adverse Events

  Number of adverse events (AEs); (assessed as related and non-related)

  From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)

• Safety and Tolerability: Injection Site Reactions

  Number of injection site reactions (dryness, redness, swelling, pain/tenderness and itching)

  From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)

• Safety and Tolerability: Clinical Laboratory Evaluations

  Number of clinically significant laboratory abnormalities

  From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)

• Safety and Tolerability: Immune Reactions

  Number of immune reactions (hypersensitivity, cytokine release syndrome, immunogenicity)

  From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)

• Safety and Tolerability: Electrocardiogram (ECG)

  Number of clinically significant abnormal findings recorded by investigator based on HR, PR, QRS and QT values of ECG

  From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)

• Safety and Tolerability: Vital Signs - Temporal Body Temperature

  Number of clinically significant abnormal findings - Temporal Body Temperature

  From screening through study completion: screening, pre-dose, 1, 4, 24, 48, 72 hours and Days 14, 21, 49 and 90 (cohorts 1-5 and 7). For cohort 6: screening, pre-dose, 1, 4, 24, 72 hours and Days 8, 29, 57, 85, 86, 88, 92,169

• Safety and Tolerability: Vital Signs - Pulse Rate

  Number of clinically significant abnormal findings - Pulse rate

  From screening through study completion: screening, pre-dose, 1, 4, 24, 48, 72 hours and Days 14, 21, 49 and 90 (cohorts 1-5 and 7). For cohort 6: screening, pre-dose, 1, 4, 24, 72 hours and Days 8, 29, 57, 85, 86, 88, 92,169

• Safety and Tolerability: Vital Signs - Blood Pressure

  Number of clinically significant abnormal findings - Blood pressure

  From screening through study completion: screening, pre-dose, 1, 4, 24, 48, 72 hours and Days 14, 21, 49 and 90 (cohorts 1-5 and 7). For cohort 6: screening, pre-dose, 1, 4, 24, 72 hours and Days 8, 29, 57, 85, 86, 88, 92,169

Secondary Outcomes (8)

• PK Parameters for SOL-116: AUC0-inf

  Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169

• PK Parameters for SOL-116: AUC0-t

  Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169

• PK Parameters for SOL-116: Cmax

  Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169

• PK Parameters for SOL-116: Tmax

  Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169

• PK Parameters for SOL-116: T1/2

  Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169

Study Arms (2)

SOL-116 single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)

EXPERIMENTAL

Biological: SOL-116

Placebo single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)

PLACEBO COMPARATOR

Biological: Placebo

Interventions

SOL-116 BIOLOGICAL

Participants will receive SC injection in a double-blind manner

SOL-116 single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)

Placebo BIOLOGICAL

Participants will receive SC injection in a double-blind manner

Placebo single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study and is willing and able to abide by the study restrictions.
• Males and females aged between 18 and 65 years (inclusive) at Screening. For patients in the RA cohort, an age interval between 18 and 70 years (inclusive).
• Normal clinically physical findings, apart from RA specific findings (including deviating laboratory values e.g., mild anaemia or swollen joints) for RA patients, including pulse rate, blood pressure, electrocardiogram (ECG), physical examination, and laboratory values (haematological/clinical chemistry) as judged by the Investigator. Healthy subjects must be negative for anti-CCP and have Rheumatoid Factor \<1.5 ULN at Screening.
• For Parts 1 and 3, body mass index (BMI) between 19.0 and 30.0 kg/m2 and body weight between 50 to 100 kg (inclusive) at Screening. For Part 2, body weight between 50 to 120 kg (inclusive) at Screening.
• Sexually active male patients participating in the study must use a barrier method of contraception (condom) and refrain from sperm donation during the study and for at least 150 days after last dosing if their female sexual partner is of childbearing potential. Acceptable methods of birth control for female partners of male subjects are: hormonal contraceptives (oral contraceptives, implant or injection), intrauterine device (placed at least 1 month before the start of the study). Surgical sterilization of male patients can be accepted as a form of birth control if the sterilization procedure took place at least 6 months prior to the start of the study.
• Females of childbearing potential must during the study and for at least 230 days after last dosing utilise a method of contraception that can achieve a failure rate of less than 1% per year when used consistently and correctly (defined in study protocol).
• Females of non-childbearing potential must fulfil one of the following:
• Irreversibly surgically sterile i.e., hysterectomy, bilateral salpingectomy, the fallopian tubes have been blocked or sealed (sterilization), and bilateral oophorectomy.
• Spontaneous amenorrhoea during the last 12 months prior to enrolment, and having follicle stimulating hormone (FSH) levels in the postmenopausal range (i.e. ≥ 30 mIU/mL) at Screening.
• Fulfilling the 2010 American College of Rheumatology (ACR)/European Union League Against Rheumatism (EULAR) classification criteria for RA \[8\].
• Treatment with MTX for at least 12 weeks prior to treatment start and planned to continue with MTX during the study; if the MTX dose was changed during the 12-week period, such a patient may be included in the study based on Investigator judgement.
• Patients naïve to biological disease modifying anti-rheumatic drug (bDMARD) or who are washed out (at least 5 half-lives) from such therapy before study drug dosing.
• Patients naïve to conventional/targeted synthetic disease modifying anti-rheumatic drug (csDMARD/tsDMARD), except for MTX, or who are washed out since at least 12 weeks from such therapy before study drug dosing.
• Use of oral glucocorticosteroids is allowed if equivalent to ≤5 mg/day of prednisolone on a stable dose for a least 4 weeks prior to dosing (Day 1) and expected to remain on that dose level for at least 4 weeks after dosing (Day 1).

You may not qualify if:

• History of any clinically significant acute inflammatory joint disease (for the RA cohort; other than RA).
• Any chronic or long-lasting disease which may interfere with the study objectives or jeopardise the safety of the subjects/patients as judged by the Investigator or responsible physician (for the RA cohort; other than RA).
• Ongoing infection on Day-1.
• Serious infection treated with antibiotics and evaluated by physician in the past 14 days prior to Day -1.
• Current treatment with heparin products.
• Use of any prescription or non-prescription drugs (excluding paracetamol, hormonal contraceptives), antacids, herbal, and dietary supplements (including St John's Wort) within 14 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug for healthy subjects and within 4 weeks prior to the first dose of study drug for RA patients, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject/patient safety. In RA patients, MTX and folic acid use are exempted.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 2.0 times upper limit of normal (ULN); alkaline phosphatase and bilirubin ≥ 1.5 times the ULN at Screening or on Day -1. At screening, these assessments may be repeated once, at the discretion of the Investigator.
• Serum creatinine \> 1.5 times the ULN or eGFR \<60 at Screening or on Day -1 (for Part 1 and Part 3). Estimated glomerular filtration rat (eGFR) \<60 at Screening or on Day -1 (for Part 2). At Screening, these assessments may be repeated once, at the discretion of the Investigator.
• Subjects/patients who have experienced surgery within 6 months of the screening visit that could negatively impact on the subject's/patient's participation in the opinion of a Principal Investigator or responsible physician.
• High blood pressure at Screening or on Day -1, judged as clinically relevant by a Principal Investigator or responsible physician. A repeat test may be performed.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at Screening.
• Having evidence of active TB or latent TB at Screening as assessed by chest X-ray (RA patients only) and/or by QuantiFERON®-test. Applicable for RA patients only: in case of rescreening within three months after Screening, negative results from the initial chest X-ray and/or QuantiFERON®-test performed during Screening do not need to be repeated.
• Subjects/patients who are currently enrolled in or have recently participated in another interventional clinical study defined as having received the last intervention within 90 days or 5 half-lives of the study drug (whichever is longer) prior to dosing (Parts 1 and 2) vs. prior to first dosing (Part 3) of the study drug.
• History or known hypersensitivity or allergy, or any form of allergic reactions to any excipients in the study drug or to humanized or murine monoclonal antibodies (or immunoglobulins).
• Receipt of a vaccine within 4 weeks (COVID-19 vaccine within 6 weeks) prior to dosing and/or the intention to receive a vaccine during the study. Deviation from this should be judged by the Investigator and in dialogue with the Sponsor.

Sponsors & Collaborators

• Lipum AB: lead
• QPS Netherlands B.V.: collaborator

Study Sites (2)

QPS Netherlands B.V.

Groningen, Netherlands

Location

CHDR (Stichting Centre for Human Drug Research)

Leiden, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Peter Hovstadius, Chief Medical Officer
• Organization: Lipum AB

peter.hovstadius@lipum.se

0046708893335

Study Officials

• Khalid Abd-Elaziz, MD

  QPS Netherlands B.V.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 single dose: Dose escalation in healthy subjects (up to 6 cohorts). Within each cohort, subjects will be randomized in a 3:1 ratio to receive either SOL-116 (n=6) or matching placebo (n=2) in a double-blind manner. Part 2 single dose in patients with rheumatoid arthritis (1 cohort). The patients will be randomized in a 3:1 ratio to receive either SOL-116 (n=6) or matching placebo (n=2) in a double-blind manner. Part 3 multiple dose in healthy subjects (1 or 2 cohorts). The subjects will be randomized in a 3:1 ratio to receive either SOL-116 (n=6) or matching placebo (n=2) in a double-blind manner.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 12, 2022
• Study Start: October 13, 2022
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)