Safety and Tolerability of Single and Multiple Doses of Neumifil

NCT05093530 | Completed Phase 1 Results

• 1 other identifier: PNG-NMF-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of Neumifil, administered intranasally.

Conditions

Viral Respiratory Tract Infection

Outcome Measures

Primary Outcomes (4)

• Part A Treatment Emergent Adverse Events

  Number of participants with Treatment Emergent Adverse Events

  7 days

• Part B: Treatment Emergent Adverse Events

  Number of participants with Treatment Emergent Adverse Events

  14 days after last dose

• Part A: Clinically Significant Changes in Safety Tests

  Number of participants with clinically significant changes in:vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire

  7 days

• Part B:Clinically Significant Changes in Safety Tests

  Number of participants with clinically significant changes in: vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), FEV1, FVC, physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire

  14 days after last dose

Other Outcomes (4)

• SARS-CoV-2 Infection Test

  Screening, before first dose, Day 8 (Part B only), follow-up (Part A: Day 8 to 9); Part B: Day 21 to 23)

• Part B: Immunoglobulin A and G (IgA and IgG) Concentrations

  Blood samples before first dose, follow-up (Day 21 to 23)

• Part A: Plasma Concentration of Neumifil

  Day 1 after single dose

Study Arms (2)

Neumifil

EXPERIMENTAL

Neumifil will be administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril, with adjusted concentrations of solution to enable dose ranging. Participants in Part A will receive a single dose of Neumifil and participants in Part B will receive once daily doses of Neumifil for 7 days according to the randomization. Ascending single doses for Part A are anticipated to be 0.028mg (group A1), 0.085mg (group A2), 0.28mg (group A3), 0.885mg (group A4) and 2.8mg (group A5). Two further groups of up to 9 subjects may be investigated. The planned dose levels may change following review of the safety and tolerability of previous doses. The maximum dose will not exceed 2.8mg. The starting dose level (dose and dose regimen) in Part B will be determined following review of the safety and tolerability of at least 3 dose levels in part A and subsequent dose levels will be determined following review of the safety and tolerability of previous doses.

Drug: Neumifil

Placebo

PLACEBO COMPARATOR

Placebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril. Participants in Part A will receive a single dose of placebo according to the randomization and participants in Part B will receive once daily doses of placebo for 7 days according to the randomization schedule.

Drug: Placebo

Interventions

Neumifil DRUG

Neumifil contains the active ingredient HEX17, a multivalent, glycan-targeting carbohydrate binding module (CBM). HEX17 CBM is suspended in an aqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80.

Also known as: HEX17

Neumifil

Placebo DRUG

Aqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteer, aged 18-60 years.
• BMI (Quetelet index) in the range 18.0-30.9 kg/m2.
• Able to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
• Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
• Agree to follow the contraception requirements of the trial
• Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
• Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value at the screening visit, calculated using National Health and Nutrition Examination Survey (NHANES) reference. If a subject's FEV1 or FVC is outside that range at the screening visit, the test may be repeated once on another day.
• Registered with a General Practitioner (GP) in the UK (Part A only).
• Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).

You may not qualify if:

• Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception.
• Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that in the opinion of the investigator could interfere with the objectives of the trial or the safety of the volunteer.
• Presence or history of acute or chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
• Presence or history of respiratory disease, including (but not limited to) asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, emphysema, requiring acute or chronic medication.
• Presence of nasal polyps or significant nasal abnormalities.
• Symptoms of respiratory illness (including, but not limited to, runny nose, sore throat, sneezing, coughing or wheezing) at the screening visit or before dosing on Day 1.
• Tympanic temperature \> 37.5°C at the screening visit or before dosing on Day 1.
• Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
• History of psychiatric disease, as determine by the investigator.
• History or presence of malignant disease.
• Immune-suppressed status, resulting from either disease or medication, as determined by the investigator.
• Presence or history of severe adverse reaction to any drug or the excipients of Neumifil.
• Known allergy to tetracycline antibiotics.
• Use of a prescription medicine (except HRT in female subjects), including oral contraceptives, during the 28 days before the first dose of trial medication, or use of an over-the-counter medicine, with the exception of acetaminophen (paracetamol) and vitamin or nutritional supplements, during the 7 days before the first dose of trial medication.
• Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.

Sponsors & Collaborators

• Pneumagen Ltd.: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

Location

Results Point of Contact

• Title: CEO
• Organization: Pneumagen Ltd

douglas.thomson@pneumagen.com

+44 7748357352

Study Officials

• Geoff Kitson

  gkitson@propharmapartners.uk.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 26, 2021
• Study Start: October 12, 2021
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2024-01

Locations

GB (1)