Status:
COMPLETED
Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects
Lead Sponsor:
UCB Celltech
Collaborating Sponsors:
Parexel
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to investigate the safety and tolerability of UCB5857.
Eligibility Criteria
Inclusion
- To be eligible to participate in this study, all of the following criteria must be met:
- An Independent Ethics Committee (IEC)-approved written Informed Consent Form is signed and dated by the subject
- Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator
- Subject is male or female, 18 to 55 years of age (inclusive)
- Female subjects must have a negative pregnancy test in urine at the Screening Visit and a negative serum pregnancy test on Day -1, and be of nonchildbearing potential, defined as being:
- Postmenopausal (for at least 2 years before the Screening Visit), verified by serum follicle-stimulating hormone (FSH) level \>40 mIU/mL at the Screening Visit, or
- Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy), or
- Congenitally sterile
- Contraception methods for male subjects and their female partners:
- Male subject with a partner of childbearing potential must be willing to use a condom when sexually active
- The female partner of childbearing potential of a male subject must be willing to use at least 2 effective methods of contraception, including a barrier method (eg, male condom, female condom, or diaphragm with spermicide) during the study period.
- Both sexes must use the above mentioned contraception methods (condoms for males) during the study and for 20 weeks after the last administration of the Investigational Medicinal Product (IMP) (anticipated 5 half-lives).
- Subject is of normal weight as determined by a body mass index (BMI) of 18.0 to 30.0 kg/m\^2 (inclusive), with a body weight of at least 50 kg
- Subject has clinical laboratory test results within the reference ranges of the testing laboratory
- Subject has Blood Pressure (BP) and pulse within normal range in a supine position after 5 minutes rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse: 40 to 90 beats per minute - all inclusive)
- Subject's ECG is considered "normal" or "abnormal but clinically nonsignificant" (as interpreted by the Investigator)
Exclusion
- Subjects are not permitted to enroll in the study if any of the following criteria is met:
- Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)
- Subject is considered anti-high-affinity immunoglobulin E (IgE) receptor nonresponsive if CD63 induction on basophils is \<10 %
- Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, and peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status
- Subject has diabetes mellitus of any type requiring insulin
- Subject has
- an active infection (eg, sepsis, pneumonia, abscess)
- history of latent, chronic, or recurrent infections (eg, tuberculosis \[TB\], recurrent sinusitis, genital herpes, urinary tract infections) or at risk of infection (surgery, trauma, infection requiring antibiotics, history of skin abscesses) within 3 months before IMP administration
- experienced a significant episode of gastroenteritis (defined as loose stools associated with abdominal pain and/or fever) during the 7 days before IMP administration
- When in doubt, the Investigator should confer with the Sponsor's Study Physician.
- Subject has a history of positive TB test or evidence of possible TB or latent TB infection at the Screening Visit (QuantiFERON® Gold Test)
- Subject has received live attenuated vaccination within 3 months or any other type of vaccine within 4 weeks before the Screening Visit or intends to have such a vaccination during the course of the study
- Subject who has any of the following hematology values at the Screening Visit: Hemoglobin; for women \<11 g/dL; for men \<13 g/dL Absolute Neutrophil Count (ANC) \<1.5 x 109/L (\<1000/mm\^3)
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02207595
Start Date
August 1 2014
End Date
February 1 2015
Last Update
March 5 2015
Active Locations (1)
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1
Harrow, United Kingdom