Clinical trial: Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects (NCT02207595)

Eligibility criteria:
Inclusion Criteria:

        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:

               1. 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

               2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
                  salpingectomy), or

               3. Congenitally sterile

          -  Contraception methods for male subjects and their female partners:

               1. Male subject with a partner of childbearing potential must be willing to use a
                  condom when sexually active

               2. 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 Criteria:

        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

               1. an active infection (eg, sepsis, pneumonia, abscess)

               2. 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

               3. 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)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction