A randomized, double-blind, placebo-controlled investigation of the safety, tolerability and pharmacokinetics of 1% SPL7013 nasal spray in healthy volunteers when administered four times a day for 14 days

Phase 1

Completed

• Conditions: COVID-19; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620001371987
• Lead Sponsor: Starpharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-22
• Study Completion: 2021-03-29
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Male and female, aged 18 to 65 years, inclusive.
2.In good general health, with no significant medical history, no clinically significant abnormalities on physical examination at screening and/or before administration of the initial application of the investigational device.
3.Body Mass Index (BMI) between 18.0 and 32.0 kg/sqm, inclusive.
4.Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate.
5.Non-smoker and must not have used any nicotine containing products within 2 months prior to screening.
6.Written informed consent signed prior to entry into the investigation.

Exclusion Criteria

1.Prior or ongoing medical condition, medical history, physical findings or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant.
2.Abnormal and/or clinically significant findings upon examination of the nasal cavity .
3.Has received an investigational drug, other investigational device, or approved therapy for investigational use within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
4.Pregnant or breastfeeding.
5.Fever (body temperature >=38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
6. Known allergy to SPL7013 or any of the spray components
7.Participant has used any kind of nasal product within 7 days prior to the start of the investigation, and/or the use of nasal products during the investigation is anticipated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including nasal cavity examination findings, physical examination findings, abnormal clinically significant vital signs (body temperature, heart rate, respiratory rate, blood pressure), 12-lead electrocardiograms (ECGs) and laboratory parameters (hematology, coagulation, chemistry and urinalysis/urine microscopy)[Day 1, Day 7, Day 15 and Day 21 (telephone follow-up only) post first dose]

Secondary Outcome Measures

Name	Time	Method
SPL7013 plasma concentration and, if detected in plasma, the AUC, Cmax, and half-life of SPL7013 assessed from plasma samples[15 min prior to and 0.25, 0.5, 1, 2, 3 and 4 hours post first dose on Day 1, and 15 min prior to and 0.25, 0.5, 1, 2, 3 and 4 hours after one of the doses (1st, 2nd, 3rd or 4th dose, depending on visit timing and availability of site staff) on Day 7.]