Safety and Tolerability of Single and Multiple Doses of Neumifil
Condition: Viral Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Part A will include up to 36 healthy subjects in up to 5 groups. 6 subjects will be enrolled
      in Groups A1-A3 and 9 subjects will be enrolled in Groups A4 and A5. All subjects will
      receive a single intranasal dose of Neumifil or placebo. In Groups A1-A3, 4 subjects will
      receive Neumifil and 2 will receive matching placebo. In Groups A4 and A5, 6 subjects will
      receive Neumifil and 3 will receive matching placebo. The planned dose levels are: 0.028 mg
      (Group A1), 0.085 mg (Group A2), 0.28 mg (Group A3), 0.885 mg (Group A4), and 2.8 mg (Group
      A5). Additional dose levels may be assessed in up to 2 optional groups of up to 9 subjects
      each (Groups A6 and A7).

      Subjects will be screened within 35 days before their dose of trial medication and reside at
      the Investigator site from the day before their dose (Day -1) until approximately 24 hours
      after dosing (Day 2). They will return for a follow-up visit on Day 8-9.

      Part B will include up to 24 healthy subjects in up to 3 groups of 8 subjects (Groups B1-B3).
      Subjects will receive once-daily intranasal doses of Neumifil or placebo for 7 days. In each
      group, 6 subjects will receive Neumifil and 2 subjects will receive matching placebo.

      The starting dose level (dose and dose regimen) for Group B1 will be decided after review of
      safety and tolerability data from at least 3 dose levels in Part A, and will be no higher
      than a dose that has previously been shown to cause no safety concerns in Part A . An
      additional dose level may be explored in 1 optional group of up to 8 subjects (Group B4).

      Subjects will be screened within 35 days before their dose of trial medication and reside. at
      the Investigator site from the day before their first dose (Day -1) until about 24 hours
      after their last dose (Day 8). Subjects will attend an outpatient visit on Days 15-16. They
      will return for a follow-up visit on Days 21-23.

      During the study, dose levels for study groups will be determined by a Safety Review
      Committee in accordance with criteria defined in the study protocol and the Investigator site
      operating procedures. Dose levels will only be increased if the safety and tolerability of
      previous dose levels are considered to be acceptable by the Safety Review Committee.
    

Intervention name(s): Neumifil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): HEX17
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled trial.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment