Thyroid Associated Ophthalmopathy
Conditions
Interventions
Ia Stage:Test group 1:Investigational Drug PHP1003+IV, single dose, 5mg/kg , IV
Ia Stage:Test group 2:Investigational Drug PHP1003+IV,single dose,10mg/kg IV
Ia Stage: Test group 3:Investigational Drug PHP1003+SC,single dose, 10mg/kg
Ia Stage:Test group 4:Investigational Drug PHP1003+IV,single dose,20mg/kg
Ia Stage:Test group 5:Investigational Drug PHP1003+IV,single dose,30mg/kg
Ib Stage:Test group 1:Investigational Drug PHP1003+IV ,Multiple dose,10mg/kg ,Q2W,three times
Ib Stage:Test group 2:Investigational Drug PHP1003+SC,Multiple dose,10mg/kg,Q2W ,three times
Ib Stage:Test group 3:Investigational Drug PHP1003+IV,Multiple dose,20mg/kg , Q2W,three times
Ib Stage:Test group 4:Investigational Drug PHP1003+SC,Multiple dose,10mg/kg , QW,five times
Ib Stage:Test group 5:Investigational Drug PHP1003+IV,Multiple dose,30mg/kg Q2W,three times
Ia Stage:placebo control group 1:Placebo Nacl + IV,single dose,5mg/kg
Ia Stage:placebo control group 2:Placebo Nacl + IV,single dose, 10mg/kg
Ia Stage:placebo control group 3:Placebo Nacl + SC,single dose, 10mg/kg
Ia Stage:placebo control group 4:Placebo Nacl + IV,single dose,20mg/kg
Ia Stage:placebo control group 5:Placebo Nacl + IV,single dose,30mg/kg
Ib Stage:placebo control group 1:Placebo Nacl + IV ,Multiple dose, 10mg/kg ,Q2W, three times
Ib Stage:placebo control group 2:Placebo Nacl + SC,Multiple dose, 10mg/kg ,Q2W ,three times
Ib Stage:placebo control group 3:Placebo Nacl + IV,Multiple dose, 20mg/kg , Q2W ,three times
Ib Stage:placebo control group 4:Placebo Nacl + SC ,Multiple dose, 10mg/kg , QW ,five times
Ib Stage:placebo control group 5:Placebo Nacl + IV ,Multiple dose, 30mg/kg , Q2W ,three times
Sponsors
Shanghai Ninth people's Hospital,Shanghai jiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects (male and female) aged 18-50 (inclusive) who signed the ICF; 2. Body mass index (BMI) = weight (kg)/height (m) 2, within the range of 19.0 to 26.0 kg/m2, and within the range of 50 to 80 kg (including the cut-off); 3. The subject is in good health condition (medical evaluation by the study doctor based on the results of medical history, physical examination, laboratory examination and electrocardiogram, etc., and the evaluation result is normal or abnormal without clinical significance); 4. Can comply with the requirements during the test, can carry out various physical examinations and laboratory tests according to the provisions of the test protocol, and can report subjective symptoms; 5. Female subjects of reproductive age must meet the following two conditions: A. consent to use a medically approved contraceptive method from the beginning of the screening period until 180 days after the last dose; B. Blood pregnancy test results at screening were negative; 6. Subjects (including male subjects) are willing to have no fertility plan and take effective contraceptive measures voluntarily in the next 180 days, and have no sperm or egg donation plan; 7. After understanding the purpose of the test, the nature of the test drug, the possible risks of the test, and their rights and interests, the subject voluntarily participated in the test and signed the ICF voluntarily.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to any component of the test drug, or allergic constitution (previous allergy to more than 2 substances); 2. Abnormal physical examination and vital signs; 3. Abnormal thyroid/abdominal color ultrasound and 12-lead ECG results, which were clinically significant as judged by the investigator; 4. Abnormal results of laboratory tests (blood routine examination, blood biochemical examination, urine routine examination, etc.) (especially the results of blood glucose and glycosylated hemoglobin, which are beyond the normal range and cannot be included in the study); 5. The result of hearing examination (pure tone hearing threshold test) may affect the safety evaluator according to the judgment of the researcher; 6. Current or long-term history of the following diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric or cardiovascular diseases) or, according to the opinion of the investigator, the disease has a potential safety risk or affects the pharmacokinetic evaluation; 7. ECG examination showed: myocardial ischemia, arrhythmia, QT prolongation, atrioventricular block and other abnormal ECG results; 8. Vital signs: Systolic blood pressure >= 140? MmHg or & lt; 90? MmHg, diastolic blood pressure >= 90? MmHg or & lt; 50? MmHg, pulse & GT; 100 beats/min or & LT; 50 times/min, ear temperature & GT; 37.5 ? or & lt; 35.5 ?; 9. Subjects who are positive for hepatitis B surface antigen (HBsAg), human immunodeficiency virus antibody (anti-HIV), hepatitis C antibody (anti-HCV), and Treponema pallidum antibody; 10. Smoking more than 5 cigarettes per day or habitual use of nicotine-containing products within 3 months before screening; 11. Drinking more than 14 units of alcohol per week in the 3 months prior to screening (1 unit of alcohol is 360 mL beer or 45 ML 40% alcohol spirits or 150? ML wine) or has consumed alcoholic products within 24 hours before the first medication or has tested positive for alcohol breath; 12. Those with a history of drug dependence, drug abuse, drug use, or positive urine drug abuse test; 13. Have used any prescription, over-the-counter, traditional Chinese medicine or herbal medicine within 28 days prior to medication; 14. Subjects have participated in other clinical studies within 3 months before screening; 15. Plan to administer any vaccine 30 days before screening until the end of the study; 16. Blood donation and/or blood loss >= 400 mL within 3 months prior to screening, or blood transfusion; Or blood donation or blood loss = 200 mL within one month before screening; 17. Patients who had suffered major injury or had undergone surgery or fracture within 3 months before screening, or planned to undergo surgery during the study period; 18. Subject cannot tolerate venipuncture; Or have a history of needle or blood sickness; 19. The female subject was lactating or had a positive serum pregnancy result during the screening period or during the test; 20.In the judgment of the investigator, the participants were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory examination(Blood routine, blood biochemistry, glycosylated hemoglobin, urine routine);Physical examination(Skin, lymph nodes, head and neck, chest and abdomen, skeletal muscle, etc.);Vital sign;12-lead electrocardiogram;Pharmacokinetic parameters;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute bioavailability index;Incidence of anti-PHP1003 antibodies; | — |
Countries
China
Contacts
Public ContactYongfang Yuan; Huifang Zhou
Shanghai Ninth people's Hospital,Shanghai jiaoTong University School of Medicine
Outcome results
None listed