Trial | NCT03058458  Report issue

Title

A First Time in Human Study of PIN201104 in Healthy Volunteers and Patients With Asthma
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pin201104 ...

  • Study Participants

    94
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.
Study Started
Jan 31
2017
Primary Completion
Jan 31
2018
Study Completion
Jan 31
2018
Last Update
Jan 25
2018

Drug PIN201104

IV or SC administration

Drug Placebo

IV or SC administration

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

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.
No Results Posted