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

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peptinnovate

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.