Investigator Site
Harrow, United Kingdom
NCT Number: NCT03058458
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Harrow, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV or SC administration
IV or SC administration
Time frame: 21 days
Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 24 hours
Cmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
Tmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
t1/2 will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
AUC0-t will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
CL/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Time frame: 24 hours
Vz/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104
Peptinnovate
Industry
A First-time-in-human, Randomised, Double-blind, Placebo-controlled, Parallel-group Study in Healthy Volunteers and Patients With Asthma to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of PIN201104
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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