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

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 - /

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007903

Enrollment

Registered

2015-03-20

Start date

2015-04-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

Group 1: Humira ® (Adalimumab), 25 mg (needle-free injection), for 1 day (single-dose) Group 2: Humira ® (Adalimumab), 25 mg (subcutaneous injection), for 1 day (single-dose)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
- AUC0-t and Cmax of adalimumab in plasma - Blood sampling for pharmacokinetics of adalimumab: : at Predose/Baseline (0), 1, 6, 12 (Day 1), 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 168 (Day 8), and 336 h (Day 15) after injection.	—

Secondary

Measure	Time frame
- tmax volume of distribution (Vd), and clearance (Cl) of adalimumab - Adverse events (AEs), local AEs at the injection site, safety laboratory, vital signs - Pain at the injection site (Visual Analogue Scale [VAS]) - NFI device usability Evaluation at the end of the study.	—

Countries

Germany

Contacts

Public ContactJutta Grabowski

CRS Clinical Research Services Mannheim GmbH

jutta.grabowski@crs-group.de+49 0621 15045 111

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026