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

Peptinnovate

Status and phase: Completed; Phase 1

Conditions: Asthma; Healthy Volunteers

Treatments: Drug: Placebo; Drug: PIN201104

Study type: Interventional

Funder types: Industry

Identifiers

NCT03058458

C1104-001

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

94 participants in 4 patient groups

SAD PIN201104 in Healthy Volunteers (HV)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PIN201104

Repeat dose PIN201104 in HV

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PIN201104

Single dose PIN201104 in asthma patients

Experimental group

Description:

PIN201104 or placebo IV administration, single dose, 2 cohorts

Treatment:

Drug: Placebo

Drug: PIN201104

Single SC dose in HV

Experimental group

Description:

PIN201104 or placebo SC administration, single dose, 1 cohort

Treatment:

Drug: Placebo

Drug: PIN201104