rheumatoid arthritis (RA)
Conditions
Interventions
SOL-116 (100 mg/mL) - subcutaneous administration or Matching placebo (saline 
or vehicle) - subcutaneous administration
Sponsors
Lipum AB
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to give written informed consent for participation in the study and is willing and able to abide by the study restrictions. 2. 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). 3. 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. 4. 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. 5. 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. 6. 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. Such highly effective birth control methods include: • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable • intrauterine device (IUD) • intrauterine hormone-releasing system (IUS) • bilateral tubal occlusion • vasectomized partner • sexual abstinence 7. 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: 8.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 inc
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant acute inflammatory joint disease (for the RA cohort; other than RA). 2. 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). 3. Ongoing infection on Day-1. 4. Serious infection treated with antibiotics and evaluated by physician in the past 14 days prior to Day -1. 5. Current treatment with heparin products. 6. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (type, frequency, severity, and relationship of adverse events (AEs) to study drug treatment), clinical laboratory evaluations (including blood haematology/plasma biochemistry analyses and urinalyses), immune reactions, vital signs, electrocardiogram (ECG) and injection site reactions. | — |
Secondary
| Measure | Time frame |
|---|---|
| All parts • PK of SOL-116 variables: area under the serum concentration-time from time zero to infinity (AUC0-inf), AUC from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t), maximum observed serum concentration (Cmax), time to Cmax (Tmax), terminal elimination half-life (T1/2), apparent volume of distribution (Vz/F), apparent total body clearance (CL/F) and dose proportionality after single dose (based on AUC and Cmax). • Incidence and titre of anti-drug antibodies (ADA) to SOL-116. Multiple dosing • PK of SOL-116 variables for the last dose: area under the serum concentration-time from time zero to the end of dosing interval (AUC0-tau), maximum observed serum concentration (Cmax), time to Cmax (Tmax), minimum observed serum concentration (Ctrough), average serum concentration (Cave), apparent total body clearance at steady state (CLss/F), time to steady state, accumulation ratio in Cmax and AUC0-tau | — |
Countries
Netherlands
Outcome results
None listed