A study to compare a single dose of M923, EU-sourced Humira or US-sourced Humira in healthy volunteers

Phase 1

Completed

• Conditions: Healthy adult volunteers; Not Applicable

• Registration Number: ISRCTN70649397
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-16
• Study Completion: 2015-08-26
• Last Update Posted: 14 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

1. Male or females of non-childbearing potential aged 18 to 55 years, inclusive
2. Healthy as determined by pre study medical history, physical examination, vital signs and 12-lead ECG
3. Clinical laboratory test results that are not clinically significant and are acceptable to the investigator at screening and admission to the clinical unit (Day -1)
4. Body weight between 60.0 and 100.0 kg and a body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
5. Male subjects must have been vasectomized with confirmation of sterility or be willing to comply with the contraception restrictions for this study
6. Female subjects must have a negative pregnancy test at screening and on admission to the clinical unit (Day -1), must not be lactating, and must be of non-childbearing potential
7. Has smoked =10 cigarettes or 3 cigars or 3 pipes/day for at least 3 months prior to screening and is willing to comply with smoking restrictions during confinement at the study center
8. Willing and able to comply with the requirements of the study
9. Willing and able to sign a written informed consent

Exclusion Criteria

1. Clinically significant allergic or hypersensitivity conditions
2. Tuberculosis, invasive systemic fungal infections, other severe opportunistic infections, recent serious infection, recent or recurrent herpes zoster infection, chronic or recurrent infections
3. Recent or planned other investigational trial participation
4. Alcohol abuse or drug abuse
5. Recent use of any prescribed or non prescribed medication other than paracetamol, vitamins and for females, hormone replacement therapy
6. Congestive heart failure
7. Signs or symptoms of demyelinating disease
8. Cancer
9. Impaired liver function
10. Immunodeficiency or other clinically significant immunological disorders
11. Anti-citrullinated protein antibodies at screening
12. Anti-drug antibodies to adalimumab at screening
13. Clinically relevant history or presence of medical disorders as judged by the investigator
14. Recent or planned receipt during the study of a live vaccine
15. Medical dietary restrictions
16. Subjects who cannot communicate reliably

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Observed maximum concentration (Cmax)<br> 2. Area under the serum concentration-time curve from time zero to 336 hours [AUC(0-336)]<br> 3. Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(0-inf)]<br> PK blood samples will be taken pre-dose and up to and including Day 71 post-dose.<br>