Clinical trial NCT03058458: A First Time in Human Study of PIN201104 in Healthy Volunteers and Patients With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Asthma
Lead sponsor: Peptinnovate
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects of non-childbearing potential age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
* Written informed consent must be obtained before any assessment is performed.
* Able to communicate well with the Investigator/designee.

Exclusion Criteria:

* Any known reaction to study drug or components
* concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
* No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
* Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
* Excessive use of caffeine-containing beverages
* Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.
* History of regular alcohol consumption within 6 months of screening 10.
* Positive screen for drugs-of-abuse or cotinine.
* Blood donation in excess of 500mL within 3 months.
* Participation in another study with an experimental drug within 3 months of first IMP administration.
* Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.
* Ongoing rhinitis that requires treatment.
* Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine 14 days before dosing with study drug until telephone follow-up.

Primary outcomes:
measure: Number of subjects with TEAEs and number of events will be summarised by treatment
timeFrame: 21 days
Secondary outcomes:
measure: Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment.
timeFrame: 14 days
measure: Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment.
timeFrame: 14 days
measure: Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment.
timeFrame: 14 days
measure: Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment.
timeFrame: 14 days
measure: Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax)
timeFrame: 24 hours
measure: PK of PIN201104: The time to reach Cmax (Tmax)
timeFrame: 24 hours
measure: PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2)
timeFrame: 24 hours
measure: PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t)
timeFrame: 24 hours
measure: PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F)
timeFrame: 24 hours
measure: PK of PIN201104: Apparent volume of distribution (Vz/F)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Investigator Site
Study officials:
affiliation: Parexel
name: Muna Albayaty, MBChB
role: PRINCIPAL_INVESTIGATOR
References: