A single-center, randomized, single-blinded, controlled, pilot study to investigate the delivery of adalimumab after subcutaneous injection with a needle free injection device compared to injection with a syringe
- Conditions
- Healthy Volunteers
- Registration Number
- DRKS00007903
- Lead Sponsor
- IIS Innovative Injektions-Systeme GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36
1. Subjects who are able to understand and follow instructions during the study.
2. Signed informed consent.
3. Male or female.
4. White.
5. Age between 18 and 45 years (inclusive).
6. In general good physical health as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and
clinical laboratory tests.
7. Weight within the normal range according to accepted values for the Body mass index within 18.0 to 29.4 kg/m2.
8. Normal blood pressure.
9. A heart rate above 50 or below 100 beats per min measured after at least 5 min rest in supine position.
10. ECG recording without clinically significant
abnormalities.
There are additional details/criteria.
1. More than moderate smoker (>10 cigarettes/day).
2. More than moderate alcohol consumption.
3. Any history of alcohol or drug abuse.
4. Use of any medication within 2 weeks before first dosing.
5. Blood donation within 30 days before signing
informed consent to this trial.
6. Demonstrating any active physical disease, acute or chronic.
7. Any history of drug hypersensitivity, asthma,
urticaria or other severe allergic diathesis as well as current hay fever.
8. Any history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, and bleeding tendency.
9. Laboratory values outside the reference range that are of clinical relevance.
10. Positive test for human immunodeficiency virus (HIV) antibodies or antigen.
11. Positive Hepatitis B-virus surface antigen (HBsAg) test.
12. Positive Anti-hepatitis C-virus antibodies (Anti-
HCV) test.
13. Pregnant or nursing women.
14. Women of childbearing potential not using a highlyeffective method of birth control.
There are additional details/criteria.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - AUC0-t and Cmax of adalimumab in plasma<br>- Blood sampling for pharmacokinetics of adalimumab: : at Predose/Baseline (0), 1, 6, 12 (Day 1), 24 (Day 2), 48 (Day 3), 72 (Day<br>4), 96 (Day 5), 120 (Day 6), 168 (Day 8), and 336 h (Day 15) after<br>injection.
- Secondary Outcome Measures
Name Time Method - tmax volume of distribution (Vd), and clearance (Cl) of adalimumab<br>- Adverse events (AEs), local AEs at the injection site, safety laboratory,<br>vital signs<br>- Pain at the injection site (Visual Analogue Scale [VAS])<br>- NFI device usability<br><br>Evaluation at the end of the study.