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

A Phase 1 study testing SOL-116 in people with Rheumatoid Arthritis, run by Lipum AB at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: SOL-116
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 2 sitesNetherlands
Study dates: 13 Oct 2022to 28 Nov 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

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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.
The following inclusion criterion is only applicable for RA patients:
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).

Who cannot join

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.

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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.
Recent confirmed COVID-19 infection, with less than 6 weeks between recovery and dosing of study drug.
Blood or plasma donation within 3 months of enrolment.
Positive urine drug screen or alcohol test at Screening or on Day -1.
History of drug or alcohol abuse, at the discretion of the Investigator, within past 12 months prior to Screening.
The subject currently smokes or uses nicotine-containing products. Former smokers will be eligible, provided they have not smoked for at least 1 month prior to Screening. Positive cotinine test results at Screening or on Day -1 are reason for exclusion. Such positive test results can be repeated once to exclude environmental influence on the subject.
A positive pregnancy test or lactation at Screening or on Day -1.
The following exclusion criteria are only applicable for RA patients:
Intra-articular or systemic corticosteroid injection within 4 weeks prior to dosing.
Current or expected need of other immunosuppressant medication except MTX and/or intra-articular corticosteroid injections.
Known Gilbert's syndrome or Screening laboratory values indicating Gilbert's syndrome.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

QPS Netherlands B.V.
Groningen
CHDR (Stichting Centre for Human Drug Research)
Leiden

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of SOL-116 in Healthy Subjects and Patients With Rheumatoid Arthritis

Conditions: Rheumatoid Arthritis
Being tested: SOL-116, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SOL-116Biological
Participants will receive SC injection in a double-blind manner
PlaceboBiological
Participants will receive SC injection in a double-blind manner

Study groups in NCT05576012
Study group	Role	What they receive
SOL-116 single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)	Experimental	Not described Receives: Biological: SOL-116
Placebo single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability: Adverse Events
Number of adverse events (AEs); (assessed as related and non-related)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Area under the concentration-time curve up to infinite time
Measured: 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
Area under the concentration-time curve up to the last measurable concentration
Measured: 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
Maximal observed concentration (Cmax)
Measured: 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
Time to Cmax
Measured: 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
Outcome measure: Terminal elimination half-life
Measured: 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: Vz/F
Apparent volume of distribution following extravascular administration
Measured: 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: CL/F
Apparent total body clearance following extravascular administration
Measured: 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
Immunogenicity Parameters: ADA
Number of samples with detectable ADA (anti-drug antibodies)
Measured: Cohorts 1-5 and 7: Pre-dose, 4h, days 8, 21, 49 and 90. Cohort 6: Pre-dose, days 29, 57, 85, 113 and 169.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Oct 202228 Nov 2024

First posted12 Oct 2022
Study start13 Oct 2022
Primary completion28 Nov 2024
Study completion28 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05576012
Sponsor's protocol ID: LPM-116-001
Status last verified: Dec 2025
First submitted: 3 Oct 2022
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Meijs AC, Kolmert J, Lindquist S, Hovstadius P, Grievink HW, Hallgren A, Wennerholm A, Klarenbeek NB, Hernell O. First-in-human (phase I) trial of SOL-116, a humanised IgG4 monoclonal antibody targeting bile salt-stimulated lipase, in healthy participants and rheumatoid arthritis patients. RMD Open. 2026 Jun 22;12(2):e006712. doi: 10.1136/rmdopen-2026-006712.
PubMed 42331396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of SOL-116 in Healthy Subjects and Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT05576012
Acronym / sponsor ID: LPM-116-001
Conditions: Rheumatoid Arthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Lipum ABIndustry (pharma, biotech, devices)
Collaborators: QPS Netherlands B.V.
Study start: 13 Oct 2022 (actual)
Primary completion: 28 Nov 2024 (actual)
Study completion: 28 Nov 2024 (actual)
First posted: 12 Oct 2022 (actual)
Results: Posted 8 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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.

Key exclusion criteria (25 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SOL-116Participants will receive SC injection in a double-blind manner	Biological	SOL-116 single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)
PlaceboParticipants will receive SC injection in a double-blind manner	Biological	Placebo single dose (Parts 1 and 2); multiple dose (Part 3) (SC administration)

Primary outcome

Safety and Tolerability: Adverse Events
Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)
Number of adverse events (AEs); (assessed as related and non-related)
Safety and Tolerability: Injection Site Reactions
Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)
Number of injection site reactions (dryness, redness, swelling, pain/tenderness and itching)
Safety and Tolerability: Clinical Laboratory Evaluations
Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)
Number of clinically significant laboratory abnormalities
Safety and Tolerability: Immune Reactions
Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)
Number of immune reactions (hypersensitivity, cytokine release syndrome, immunogenicity)
Safety and Tolerability: Electrocardiogram (ECG)
Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)
Number of clinically significant abnormal findings recorded by investigator based on HR, PR, QRS and QT values of ECG
Safety and Tolerability: Vital Signs - Temporal Body Temperature
Time frame: 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
Number of clinically significant abnormal findings - Temporal Body Temperature
Safety and Tolerability: Vital Signs - Pulse Rate
Time frame: 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
Number of clinically significant abnormal findings - Pulse rate
Safety and Tolerability: Vital Signs - Blood Pressure
Time frame: 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
Number of clinically significant abnormal findings - Blood pressure

8 secondary outcomes

PK Parameters for SOL-116: AUC0-inf
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: Vz/F
Time frame: 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: CL/F
Time frame: 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
Immunogenicity Parameters: ADA
Time frame: Cohorts 1-5 and 7: Pre-dose, 4h, days 8, 21, 49 and 90. Cohort 6: Pre-dose, days 29, 57, 85, 113 and 169.

Results and safety

Results posted to the registry on 8 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (Active)	6	6
Cohort 2 (Active)	6	6
Cohort 3 (Active)	6	6
Cohort 4 (Active)	6	6
Cohort 5 (Active)	6	6
Cohort 6 (Active)	6	6
Cohort 7 (Active)	6	6
Placebo (Cohort 1-5)	10	10
Placebo (Cohort 6)	2	1
Placebo (Cohort 7)	2	2

Primary outcome: Safety and Tolerability: Adverse Events

Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6). Number. Unit: number of events

Measure	Cohort 1 (Single Dose) n = 6	Cohort 2 (Single Dose) n = 6	Cohort 3 (Single Dose) n = 6	Cohort 4 (Single Dose) n = 6	Cohort 5 (Single Dose) n = 6	Cohort 6 (Multiple Doses) n = 6	Cohort 7 (Single Dose) n = 6	Placebo (Cohorts 1-5) n = 10	Placebo (Cohort 6) n = 2	Placebo (Cohort 7) n = 2
Value	7	9	8	8	4	24	28	8	3	4

Population analysed: Safety set

Primary outcome: Safety and Tolerability: Injection Site Reactions

Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6). Number. Unit: number of events

Measure	Cohort 1 (Single Dose) n = 6	Cohort 2 (Single Dose) n = 6	Cohort 3 (Single Dose) n = 6	Cohort 4 (Single Dose) n = 6	Cohort 5 (Single Dose) n = 6	Cohort 6 (Multiple Doses) n = 6	Cohort 7 (Single Dose) n = 6	Placebo (Cohorts 1-5) n = 10	Placebo (Cohort 6) n = 2	Placebo (Cohort 7) n = 2
Value	0	0	1	4	3	0	3	2	0	0

Population analysed: Safety set

Primary outcome: Safety and Tolerability: Clinical Laboratory Evaluations

Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6). Count of units. Unit: samples

Measure	Cohort 1 (Single Dose) n = 6	Cohort 2 (Single Dose) n = 6	Cohort 3 (Single Dose) n = 6	Cohort 4 (Single Dose) n = 6	Cohort 5 (Single Dose) n = 6	Cohort 6 (Multiple Doses) n = 6	Cohort 7 (Single Dose) n = 6	Placebo (Cohorts 1-5) n = 10	Placebo (Cohort 6) n = 2	Placebo (Cohort 7) n = 2
Value	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety set

Primary outcome: Safety and Tolerability: Immune Reactions

Time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6). Number. Unit: events

Measure	Cohort 1 (Single Dose) n = 6	Cohort 2 (Single Dose) n = 6	Cohort 3 (Single Dose) n = 6	Cohort 4 (Single Dose) n = 6	Cohort 5 (Single Dose) n = 6	Cohort 6 (Multiple Doses) n = 6	Cohort 7 (Single Dose) n = 6	Placebo (Cohorts 1-5) n = 10	Placebo (Cohort 6) n = 2	Placebo (Cohort 7) n = 2
Value	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety set

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (SOL-116)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Cohort 2 (SOL-116)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 3 (SOL-116)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 4 (SOL-116)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 5 (SOL-116)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 6 (SOL-116)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 7 (SOL-116)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Cohorts 1-5 (Placebo)	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Cohort 6 (Placebo)	1 of 2 (50%)	2 of 2 (100%)	0 of 2
Cohort 7 (Placebo)	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42331396Meijs AC, Kolmert J, Lindquist S, Hovstadius P, Grievink HW, Hallgren A, Wennerholm A, Klarenbeek NB, Hernell O. First-in-human (phase I) trial of SOL-116, a humanised IgG4 monoclonal antibody targeting bile salt-stimulated lipase, in healthy participants and rheumatoid arthritis patients. RMD Open. 2026 Jun 22;12(2):e006712. doi: 10.1136/rmdopen-2026-006712.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Khalid Abd-Elaziz, MD principal investigator

QPS Netherlands B.V.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SOL-116 in people with Rheumatoid Arthritis, run by Lipum AB at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability: Adverse Events (time frame: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05576012, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.