Clinical trial: A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects (NCT04235933)

Eligibility criteria:
Inclusion Criteria:

          1. Voluntarily signed the informed consent as applicable to participate in the study, age
             18-55, inclusive, male: female=1:1;

          2. Body mass index between 18.5-26 kg/m², inclusive, with a body weight ≥50 kg (male),
             ≥45 kg (female);

          3. Considered "healthy" by the investigator. Healthy status is defined by absence of
             evidence of any active or chronic disease following a detailed medical and surgical
             history, as well as a complete physical examination including vital signs, 12-lead
             ECG, X-ray examination, infectious disease examination, peripheral blood cell count,
             platelet aggregation and coagulation function, blood chemistry, urine routine and
             stool routine ( include occult blood);

          4. An understanding, ability, and willingness to fully comply with study procedures and
             restrictions.

        Exclusion Criteria:

          1. History of any hematological, digestive system, respiratory, cardiovascular, renal,
             neurological, psychiatric disease, metabolic disorders or tumor, which could affect
             the action, absorption, or disposition of the investigational product, or clinical or
             laboratory assessments;

          2. History of abnormal bleeding or coagulation disorders (e.g. easy bruising, gum
             bleeding, prolonged bleeding after tooth extraction, joint hemorrhage; anemia in
             recent 1 year caused by menorrhagia, postpartum hemorrhage, vitamin K deficiency,
             haemorrhagic diseases caused by acquired coagulation factor antibodies, trauma or
             post-operative bleeding, etc.);

          3. Pregnant or lactating female during screening period; subjects and their partners did
             not agree to take effective contraceptive measures (such as intrauterine devices,
             contraceptives or condoms) throughout the study period and within 30 days after the
             end of the visit period;

          4. History of allergic to therapeutic or diagnostic protein products, allergic to two or
             more drugs and/or non-drug factors; suffering from allergic diseases;

          5. History of surgery within six months before signing the informed consent; Willing to
             undergo surgery within two weeks after the end of the trial (including cosmetic
             surgery, dental surgery, oral surgery, etc.);

          6. Participated an investigational product in recent 3 months;

          7. Current use of any prescription or over-the-counter (herbal, vitamins, or healthcare
             products). Current use is defined as use within 14 days or PK equivalent of 5
             half-lives, whichever is longer;

          8. History of Bleeding or donated more than 400ml blood 3 months before screening period,
             or plan to denote blood within 1 month after the trial;

          9. Consume more tobacco or alcohol (≥14 units of alcohol per week: one standard unit
             contains 14g of alcohol, equals to 360ml of beer, 45ml of 40% liquor or 150ml of wine;
             smokers with more than 5 cigarettes per day.);

         10. Consume excessive caffeine-containing beverages, foods that may affect drug metabolism
             within four weeks before signing informed consent: coffee (≥1100 mL per day), tea
             (≥2200 mL per day), cola (≥2200 mL per day), energy drinks (≥1100 mL per day),
             chocolate (≥510 g per day);

         11. Positive HIV, HBsAg, Hepatitis C virus, Tubercle Bacillus antibody screen;

         12. Researchers believe that there are other factors that are not suitable for
             participating in the experiment.
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 50 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Contradiction