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About
This is a Phase 1 single center, parallel group study to assess and compare the safety, tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg) following subcutaneous administration in healthy Japanese and Caucasian subjects.
Full description
Twenty-four healthy eligible Japanese male subjects and 24 healthy eligible Caucasian male subjects, each divided into 4 cohorts of 6 subjects, will participate in this study. No subject will participate in more than 1 cohort and all subjects will receive a single dose of P1101. Caucasian subjects will be body weight- and height-matched to Japanese subjects.
Dosing will be initiated with the lowest dose of 100 μg in both Japanese and Caucasian subjects.
Enrollment
Sex
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Volunteers
Inclusion criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:
Exclusion criteria
Subjects are excluded from the study if any of the following criteria apply:
Subjects who do not conform to the above inclusion criteria.
Female subjects.
Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, coagulation, endocrine, lymphatic, neurological, cardiovascular, psychiatric, ophthalmological, musculoskeletal, genitourinary, immunological, autoimmune, dermatological, and connective tissue diseases or disorders.
Subjects who have a first degree relative with autoimmune disease (e.g. thyroiditis, lupus, rheumatoid arthritis, etc.) or other clinically relevant medical history which in the opinion of the Investigator poses a risk to the subject.
Subjects with a history of latent or active tuberculosis or exposure to endemic areas.
Subjects with a positive result in the QuantiFERON-TB Gold test and/or clinically significant abnormality on chest X-ray.
Subjects who have a clinically relevant surgical history and history of any prior malignancy.
Subjects who, in the opinion of the Investigator, have clinically relevant medical history in their immediate family (first degree relative).
Subjects with current symptoms of eczema or hay fever, or subjects with a history of hay fever requiring medication when their hay fever season starts within the expected duration of the study.
Subjects who have a history of severe allergy and severe drug reaction (e.g., anaphylaxis, or other drug reaction requiring hospitalization to beta lactam antibiotics OR any other relevant drug hypersensitivity).
Subjects who have a history of alcoholism.
Subjects who consume more than the recommended number of 14 units of alcohol per week. (1 unit = 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer).
Subjects who have a history of drug abuse.
Subjects who have abnormal vital signs, after 10 minutes supine rest (measurements may be repeated after 15 minutes at the discretion of the Investigator where they suspect that the initial values are not representative of the usual values due to some factors e.g., anxiety), defined as any of the following at Screening:
Subjects who have any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.
Subjects who have a prolonged QTcF > 450 ms or family history of long QT syndrome.
Subjects who have a significant infection such as a respiratory infection or known inflammatory process at Screening or Admission.
Subjects who have a clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to Admission (e.g., common cold, viral syndrome, flu-like symptoms, etc).
Subjects who have acute gastrointestinal symptoms at Screening or Admission (e.g., nausea, vomiting, diarrhea, and heartburn).
Subjects who have used 1 or more prescription drugs within 28 days prior to Day 1.
Subjects who have used non-prescription drugs or other products (supplements, herbal preparations, etc) with enzyme inducing properties such as St John's Wort within 28 days prior to the first administration of investigational product.
Subjects who have used other non-prescription drugs excluding routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first administration of investigational product, unless agreed as not clinically relevant by the Principal Investigator and Sponsor.
Subjects who have received any live vaccine in the 6 months prior to Screening.
Subjects who have previously been exposed to interferon or peginterferon.
Subjects who have received the last dose of investigational product within the last 3 months or within 5 times the half-life, whichever is longer and those who are on extended follow-up.
Subjects who are vegans or have medical dietary restrictions.
Subjects who have consumed grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of investigational product.
Subjects who have donated blood/plasma within 3 months of Screening or who have had any blood loss > 500 mL during the 3 months prior to Screening.
Subjects who are staff members at the investigational site.
Subjects who are Contract Research Organization staff members, Sponsor employees, and affiliates.
Subjects who cannot understand or communicate reliably with the Investigator.
Subjects who are unlikely to co-operate with the requirements of the study.
Subjects who have been shown to have a suicidal tendency following completion of the C-SSRS.
Primary purpose
Allocation
Interventional model
Masking
36 participants in 8 patient groups
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Data sourced from clinicaltrials.gov
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