Clinical trial: Single Dose Recombinant Human Follicle Stimulating Hormone Fc Husion Protein (KN015) in Healthy Volunteers (NCT03192527)

Eligibility criteria:
Inclusion Criteria:

          1. Able and willing to provide written informed consent.

          2. Agreed to take effective contraceptive measures during and 6 months after the end of
             the study period.

          3. Age between 18 to 40 years (inclusive).

          4. Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,

          5. Regular menstruation cycle (25 to 34 days, inclusive).

          6. Healthy female volunteer, normal findings in medical history and physical
             examinations.

          7. Normal findings in sex hormone examinations unless the investigator considers an
             abnormality to be clinically irrelevant for this study.

          8. Negative for human immunodeficiency virus (HIV) I and II tests, hepatitis B surface
             antigen (HBsAg), hepatitis C antibody and schaudinn's bacillus antibody at screening.

          9. Normal uterus, presence of both ovaries, unless investigator considers an abnormality
             to be clinically irrelevant for this study.

        Exclusion Criteria:

          1. Historic abuse of alcoholic beverages and drugs. Smoke ≥5 cigarettes or the equivalent
             per day. Drug screen will include the minimum the following: amphetamines,
             barbiturates, benzodiazepines, cannabis, cocaine, methadone, opiates.

          2. History of hypersensitivity to FSH, or any documented or suspected allergy to KN015 or
             the excipients of the KN015 formulation, or hypersensitivity to luteinizing hormone
             releasing hormone agonist or something like that.

          3. Any medical history of circulation, endocrine, nervous, digestive and respiratory
             systems, hematology, immunology, psychiatry and metabolic disorders and other serious
             disease history which can interfere with the test results of the study.

          4. Polycystic ovary syndrome (PCOS).

          5. Baseline of serum FSH ≥15 IU/L.

          6. History of ovarian hyperstimulation syndrome (OHSS).

          7. Experience in controlled ovarian stimulation (COS), or showed high response to FSH
             stimulation or the number of follicles over 11mm in diameter is more than 30.

          8. The history of ovarian, breast, uterus, hypothalamus, and pituitary disease was
             determined by the investigators as clinical meaningful. Previous history of thrombosis
             or tending to suffer from thrombotic disease.

          9. History of malignant disease.

         10. Failing to comply with the special requirements of diet during study.

         11. Participation in a clinical study within 3 months prior to the study.

         12. Any medical condition that, in the opinion of the investigator, would interfere with
             safety of the subject or with the objectives of the study.

         13. Abnormal physical examinational results which is determined as clinical significance
             by the researchers of the study.

         14. Abnormal vital signs and clinical significance.

         15. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 x ULN.

         16. Thyroid dysfunction which clinical significance by researchers of the study.

         17. Other abnormal laboratory tests with clinically relevance.

         18. Abnormal electrocardiogram [ECG] findings.

         19. III/IV class endometriosis, submucous myoma of uterus, endocrine abnormalities within
             6 months prior to the study.

         20. Abnormal imaging examination and clinical significance judged by researchers of the
             study.

         21. Pregnancy or lactation period.

         22. Alcohol and urine drug screening positive. -
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 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? 0