A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis
Overview
- Phase
- Phase 1
- Intervention
- placebo
- Conditions
- Inflammation
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Adverse events, including injection site tolerability
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of single doses of Anti-IL-20 in healthy volunteers (HV) and patients with rheumatoid arthritis (RA).
Investigators
Eligibility Criteria
Inclusion Criteria
- •For healthy volunteers (HV) the following applies:
- •Subjects who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator
- •Females who are post-menopausal, surgically sterile or of non-child-bearing potential
- •For rheumatoid arthritis (RA) patients the following applies:
- •A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least three months' duration prior to dosing
- •Active RA, characterised by a Disease Activity Score 28 (DAS28) greater than 3.2
- •Methotrexate treatment (stable doses of maximally 25.0 mg/week for at least 4 weeks) and concomitant intake of folic acid 1 mg/day or 5 mg/week
- •Females who are post-menopausal, surgically sterile or of non-child-bearing potential
Exclusion Criteria
- •For healthy volunteers (HV) the following applies:
- •Male subjects who do not accept to use double barrier methods of birth control from first dosing until 3 moths after their last visit
- •Body mass index (BMI) below 18.5 or above 35.0 kg/m2
- •Clinically significant cardiac or cardiovascular disease
- •Abnormal blood pressure and heart rate
- •Hepatic insufficiency
- •Renal insufficiency
- •Positive for humane immunodeficiency virus (HIV)
- •Positive for hepatitis B (HBV) or hepatitis C (HCV)
- •Lymphoproliferative disease
Arms & Interventions
C, HV
Dose cohort 3 (3 subjects active, 1 placebo)
Intervention: placebo
A, HV
Dose cohort 1 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
A, HV
Dose cohort 1 (3 subjects active, 1 placebo)
Intervention: placebo
B, HV
Dose cohort 2 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
B, HV
Dose cohort 2 (3 subjects active, 1 placebo)
Intervention: placebo
C, HV
Dose cohort 3 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
D, HV
Dose cohort 4 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
D, HV
Dose cohort 4 (3 subjects active, 1 placebo)
Intervention: placebo
E, HV
Dose cohort 5 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
E, HV
Dose cohort 5 (3 subjects active, 1 placebo)
Intervention: placebo
A, RA
Dose cohort 1 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
A, RA
Dose cohort 1 (3 subjects active, 1 placebo)
Intervention: placebo
B, RA
Dose cohort 2 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
B, RA
Dose cohort 2 (3 subjects active, 1 placebo)
Intervention: placebo
C, RA
Dose cohort 3 (3 subjects active, 1 placebo)
Intervention: anti-IL-20
C, RA
Dose cohort 3 (3 subjects active, 1 placebo)
Intervention: placebo
Outcomes
Primary Outcomes
Adverse events, including injection site tolerability
Time Frame: during treatment
Secondary Outcomes
- Maximum observed serum concentration (Cmax)(during treatment)
- Time to reach maximum serum concentration (tmax)(during treatment)
- Terminal serum half-life (t½)(during treatment)
- Relevant biomarkers in serum and plasma, as well as synovial fluid (if applicable)(during treatment)
- Area under the serum concentration-time curve (AUC0-t and AUC)(during treatment)