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

NCT03058458 | Completed Phase 1

• 1 other identifier: C1104-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of subjects with clinically significant abnormal haematology variables will be summarised by treatment.

  14 days

• Number of subjects with clinically significant abnormal clinical chemistry variables will be summarised by treatment.

  14 days

• Number of subjects with clinically significant abnormal electrocardiogram variables will be summarised by treatment.

  14 days

• Number of subjects with clinically significant abnormal vital sign variables will be summarised by treatment.

  14 days

• Pharmacokinetics of PIN201104: The maximum observed plasma concentration (Cmax)

  24 hours

Study Arms (4)

SAD PIN201104 in Healthy Volunteers (HV)

EXPERIMENTAL

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

Drug: PIN201104; Drug: Placebo

Repeat dose PIN201104 in HV

EXPERIMENTAL

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

Drug: PIN201104; Drug: Placebo

Single dose PIN201104 in asthma patients

EXPERIMENTAL

PIN201104 or placebo IV administration, single dose, 2 cohorts

Drug: PIN201104; Drug: Placebo

Single SC dose in HV

EXPERIMENTAL

PIN201104 or placebo SC administration, single dose, 1 cohort

Drug: PIN201104; Drug: Placebo

Interventions

PIN201104 DRUG

IV or SC administration

Repeat dose PIN201104 in HV; SAD PIN201104 in Healthy Volunteers (HV); Single SC dose in HV; Single dose PIN201104 in asthma patients

Placebo DRUG

IV or SC administration

Repeat dose PIN201104 in HV; SAD PIN201104 in Healthy Volunteers (HV); Single SC dose in HV; Single dose PIN201104 in asthma patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peptinnovate: lead

Study Sites (1)

Investigator Site

Harrow, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Muna Albayaty, MBChB

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 23, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

GB (1)