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Completed

NCT Number: NCT03058458

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site

Harrow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PIN201104

Drug

IV or SC administration

Placebo

Drug

IV or SC administration

Primary outcomes

  1. Number of subjects with TEAEs and number of events will be summarised by treatment

    Time frame: 21 days

    Treatment Emergent Adverse Events after single and multiple dose administration will be collected at baseline and repeated until study completion

Secondary outcomes

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

    Time frame: 14 days

    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.

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

    Time frame: 14 days

    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.

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

    Time frame: 14 days

    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.

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

    Time frame: 14 days

    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.

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

    Time frame: 24 hours

    Cmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104

  6. PK of PIN201104: The time to reach Cmax (Tmax)

    Time frame: 24 hours

    Tmax will be calculated after single and multiple IV dosing and single SC dosing of PIN201104

  7. PK of PIN201104: Apparent terminal elimination half life in plasma (t1/2)

    Time frame: 24 hours

    t1/2 will be calculated after single and multiple IV dosing and single SC dosing of PIN201104

  8. PK of PIN201104: Area under the curve from time zero to the last quantifiable concentration of PIN201104 (AUC0-t)

    Time frame: 24 hours

    AUC0-t will be calculated after single and multiple IV dosing and single SC dosing of PIN201104

  9. PK of PIN201104: Apparent plasma clearance of PIN201104 (CL/F)

    Time frame: 24 hours

    CL/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104

  10. PK of PIN201104: Apparent volume of distribution (Vz/F)

    Time frame: 24 hours

    Vz/F will be calculated after single and multiple IV dosing and single SC dosing of PIN201104

Sponsors and collaborators

Lead sponsor

Peptinnovate

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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