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

NCT ID: NCT03058458

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Healthy Volunteers; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAD PIN201104 in Healthy Volunteers (HV)

PIN201104 or placebo IV administration, single dose, 10 dose cohorts

Group Type: EXPERIMENTAL

PIN201104

Intervention Type: DRUG

IV or SC administration

Placebo

Intervention Type: DRUG

IV or SC administration

Repeat dose PIN201104 in HV

PIN201104 or placebo IV administration, 3 doses on single day, 1 cohort

Group Type: EXPERIMENTAL

PIN201104

Intervention Type: DRUG

IV or SC administration

Placebo

Intervention Type: DRUG

IV or SC administration

Single dose PIN201104 in asthma patients

PIN201104 or placebo IV administration, single dose, 2 cohorts

Group Type: EXPERIMENTAL

PIN201104

Intervention Type: DRUG

IV or SC administration

Placebo

Intervention Type: DRUG

IV or SC administration

Single SC dose in HV

PIN201104 or placebo SC administration, single dose, 1 cohort

Group Type: EXPERIMENTAL

PIN201104

Intervention Type: DRUG

IV or SC administration

Placebo

Intervention Type: DRUG

IV or SC administration

Interventions

PIN201104

IV or SC administration

Intervention Type: DRUG

Placebo

IV or SC administration

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peptinnovate

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muna Albayaty, MBChB

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

Investigator Site

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

C1104-001

Identifier Type: -

Identifier Source: org_study_id