A randomized, double-blind, placebo-controlled, first-in-human phase 1 study evaluating safety, tolerability, and pharmacokinetics of single ascending doses of SOL-116 (a humanized monoclonal anti-BSSL antibody) in healthy subjects and patients with rheumatoid arthritis.
- Conditions
- rheumatoid arthritis (RA)10003816
- Registration Number
- NL-OMON56208
- Lead Sponsor
- ipum AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
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 included in the study based on
Investigator judgement.
• Patients naïve to biological disease modifying anti-rheumatic drug (bDMARD)
or who are
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events (type, frequency, severity, and relationship of adverse events<br /><br>(AEs) to study drug treatment), clinical laboratory evaluations (including<br /><br>blood haematology/plasma biochemistry analyses and urinalyses), immune<br /><br>reactions, vital signs, electrocardiogram (ECG) and injection site reactions.</p><br>
- Secondary Outcome Measures
Name Time Method