A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786

NCT03236233 | Completed Phase 1

• 2 other identifiers: PC_RSV_0012016-000934-22
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the safety, tolerability and pharmacokinetics of single and repeat doses of PC786.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (6)

• Number of participants reporting one or more treatment-emergent adverse events (TEAE)

  Baseline up to Week 12

• Number of participants who discontinue due to an adverse event (AE)

  Baseline up to Week 12

• Number of participants who meet the markedly abnormal criteria for safety 12-lead ECG assessment at least once post dose

  Baseline up to Week 12

• Number of participants who meet the markedly abnormal criteria for vital signs assessment at least once post dose

  Baseline up to Week 12

• Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once once post dose

  Baseline up to Week 12

• Number of participants who meet the markedly abnormal criteria for safety spirometry assessment (FEV1 & FVC - measured together) at least once once post dose

  Baseline up to Week 12

Secondary Outcomes (2)

• Plasma concentration of PC786

  Day 1: Pre-dose and at multiple time points (up to 10 days) post final dose

• Mucosal lining fluid concentration of PC786

  Cohort 1 - Day 1 = 3 samples; Day 2 = 2 samples; Day 3 = 1 sample. Cohorts 2 & 3 - Day 1 = 2 samples; Day 6 = 1 sample; Day 7 = 3 samples; Day 8 = 2 samples; Days 9 & 10 - 1 sample

Study Arms (3)

Single dose - healthy subjects

EXPERIMENTAL

Drug: PC786 - Single doses; Drug: Placebo - Single doses

Repeat dose - healthy subjects

EXPERIMENTAL

Drug: PC786 - Repeat doses; Drug: Placebo - Repeat doses

Single dose - subjects with asthma

EXPERIMENTAL

Drug: PC786 - Single doses; Drug: Placebo - Single doses

Interventions

PC786 - Single doses DRUG

Safety and tolerability of single doses

Single dose - healthy subjects; Single dose - subjects with asthma

Placebo - Single doses DRUG

Safety and tolerability of single doses

Single dose - healthy subjects; Single dose - subjects with asthma

PC786 - Repeat doses DRUG

Safety and tolerability of repeat doses

Repeat dose - healthy subjects

Placebo - Repeat doses DRUG

Safety and tolerability of repeat doses

Repeat dose - healthy subjects

Eligibility Criteria

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

You may qualify if:

• All subjects (Cohorts 1, 2, 3 \& 4)
• Must be male or female, aged between 18 and 65 years inclusive (at the time of consent) who fit one of the following criteria: women of childbearing potential who are willing and able to use contraception from screening until 30 days after receipt of the final dose; Women of non-childbearing potential defined as being amenorrhoeic or have been permanently sterilised; Men who are willing and able to use contraception from the time of the first dose, until 90 days after receipt of the final dose of study medication.
• Females must have a negative serum β human chorionic gonadotropin (β-hCG) test at screening and a negative urinary pregnancy test at Day -1.
• Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
• Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and that they are willing to participate.
• Body weight ≥ 50 kg and body mass index (BMI) within the range 18 - 30 kg/m2 (inclusive).
• Average QTcF \<450 msec at screening and pre-dose.
• Vital signs assessments within normal ranges at screening and pre-dose.
• Healthy Subjects (Cohorts 1, 2 \& 3)
• Healthy as determined by a physician based on a full medical examination including medical history, physical examination and laboratory tests performed at screening and pre-dose.
• Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value and FEV1/FVC ratio \> 0.7 at screening
• Subjects with Asthma (Cohort 4)
• Documented diagnosis of asthma, first diagnosed at least 12 months prior to the screening visit.
• Subject must demonstrate a PC20 methacholine ≤ 8 mg/mL at the screening visit.
• Have an FEV1 \>60% of predicted normal value at least 6 h after the last use of a short acting β-agonist (SABA).

You may not qualify if:

• All subjects (Cohorts 1, 2, 3 \& 4)
• Any acute illness.
• Upper or lower respiratory tract infection within 4 weeks of the screening visit or randomisation.
• Use of prescription medications within 14 days of the Screening visit
• Are taking over the counter medications other than vitamins or multivitamins and herbal medication, within 14 days prior to Screening
• History of regular alcohol consumption within 6 months of the study of an average weekly intake of \>21 units for males, or \>14 units for females
• Definite or suspected history of drug or alcohol abuse within the previous 5 years.
• A smoker (regular or irregular), or has smoked or used nicotine-containing products (including e-cigarettes) within the 6 months prior to screening
• A positive test for HIV-1 \& -2 antibodies at screening.
• A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody result at screening.
• Positive test for alcohol, smoking or drugs of abuse, at screening or pre-dose
• Received an experimental drug or used an experimental medical device within 3 months before the first dose of the study drug is scheduled.
• Allergy to any of the active or inactive ingredients in the study medication.
• History of drug, or other allergy that would contraindicate participation.
• Donation of blood in excess of 500 mL within a 3 month period prior to dosing

Sponsors & Collaborators

• Pulmocide Ltd: lead

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

PC-786

Study Officials

• Malcolm J Boyce, MBChB, MD

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  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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 1, 2017
• Study Start: June 21, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

GB (1)