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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of different single and repeat doses of PIN201104 in healthy volunteers and in patients with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD PIN201104 in Healthy Volunteers (HV) | Experimental | PIN201104 or placebo IV administration, single dose, 10 dose cohorts |
|
| Repeat dose PIN201104 in HV | Experimental | PIN201104 or placebo IV administration, 3 doses on single day, 1 cohort |
|
| Single dose PIN201104 in asthma patients | Experimental | PIN201104 or placebo IV administration, single dose, 2 cohorts |
|
| Single SC dose in HV | Experimental | PIN201104 or placebo SC administration, single dose, 1 cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIN201104 | Drug | IV or SC administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with TEAEs and number of events will be summarised by treatment | Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment. | Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after single and multiple dose administration and repeated until Day 14. | 14 days |
| Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muna Albayaty, MBChB | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Harrow | United Kingdom |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo | Drug | IV or SC administration |
|
Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after single and multiple dose administration and repeated until Day 14. |
| 14 days |
| Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment. | RR-interval, PR (PQ)-interval, QRS-duration, QT-interval, QTcB, QTcF and heart rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14. | 14 days |
| Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment. | Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 14. | 14 days |
| Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax) | Cmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104 | 24 hours |
| PK of PIN201104: The time to reach Cmax (Tmax) | Tmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104 | 24 hours |
| PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2) | t1/2 will be calculated after single and multiple IV dosing and single SC dosing of PIN201104 | 24 hours |
| PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t) | AUC0-t will be calculated after single and multiple IV dosing and single SC dosing of PIN201104 | 24 hours |
| PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F) | CL/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104 | 24 hours |
| PK of PIN201104: Apparent volume of distribution (Vz/F) | Vz/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104 | 24 hours |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |