Inflammation, Rheumatoid Arthritis
Conditions
Brief summary
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.
Interventions
DRUGNNC 0141-0000-0100
Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part
DRUGplacebo
Single dose administered subcutaneously (under the skin) as a comparator at all dose levels
Sponsors
Innate Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation * Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2 * Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control * Males must be willing to use highly effective contraception * Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | from trial product administration to week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Antibodies against NNC141-0100 | from trial product administration until final visit (week 12 or longer if applicable) |
| Area under the serum concentration-time curve - SD trial part | from trial product administration until final visit (week 12 or longer if applicable) |
| Terminal half-life (t½) - SD trial part | from trial product administration until final visit (week 12 or longer if applicable) |
| Terminal half-life (t½) - MD trial part | from trial product administration until final visit (week 12 or longer if applicable) |
Countries
Germany
Outcome results
None listed