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

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 Overview

• Status: Completed
• Conditions: Asthma; Healthy Volunteers
• Intervention / Treatment: Drug: PIN201104; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Harrow, United Kingdom
    • Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SAD PIN201104 in Healthy Volunteers (HV); PIN201104 or placebo IV administration, single dose, 10 dose cohorts	Drug: PIN201104; IV or SC administration; Drug: Placebo; IV or SC administration
EXPERIMENTAL: Repeat dose PIN201104 in HV; PIN201104 or placebo IV administration, 3 doses on single day, 1 cohort	Drug: PIN201104; IV or SC administration; Drug: Placebo; IV or SC administration
EXPERIMENTAL: Single dose PIN201104 in asthma patients; PIN201104 or placebo IV administration, single dose, 2 cohorts	Drug: PIN201104; IV or SC administration; Drug: Placebo; IV or SC administration
EXPERIMENTAL: Single SC dose in HV; PIN201104 or placebo SC administration, single dose, 1 cohort	Drug: PIN201104; IV or SC administration; Drug: Placebo; IV or SC administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with TEAEs and number of events will be summarised by treatment	Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment.	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.	14 days
Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment.	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.	14 days
Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment.	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.	14 days
Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment.	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.	14 days
Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax)	Cmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104	24 hours
PK of PIN201104: The time to reach Cmax (Tmax)	Tmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104	24 hours
PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2)	t1/2 will be calculated after single and multiple IV dosing and single SC dosing of PIN201104	24 hours
PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t)	AUC0-t will be calculated after single and multiple IV dosing and single SC dosing of PIN201104	24 hours
PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F)	CL/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104	24 hours
PK of PIN201104: Apparent volume of distribution (Vz/F)	Vz/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104	24 hours

Collaborators and Investigators

• Sponsor: Peptinnovate

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: C1104-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No