A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects

Study Overview
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Brief Summary
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This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.

Official Title
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A First in Human, Randomised, Double Blind, Placebo-controlled, Three-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD & MAD) of Inhaled ETD002 in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ETD002 - single dose
* Drug: Placebo - single dose
* Drug: ETD002 - 7 day repeat dose
* Drug: Placebo - 7 day repeat dose
* Drug: ETD002 - 14 day repeat dose
* Drug: Placebo - 14 day repeat dose
* Drug: Salbutamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males & females using suitable methods of contraception or females of non-childbearing potential Consent to study participation Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2 Vital signs assessments within normal ranges Healthy as determined following physical examination at screening visit Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value Exclusion Criteria: Acute or chronic illness detected at screening visit Respiratory tract infection within 4 weeks of the screening visit Use of prescription or OTC medication within 14 days of the screening visit History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse Smoking or use of tobacco products within 6 months of screening Abnormal blood/urine laboratory screening test results Current, or history of, allergy that may be contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single ascending dose<br> | Drug: ETD002 - single dose<br>* Single ascending doses of ETD002<br>Drug: Placebo - single dose<br>* Single doses of placebo<br>|
| Experimental: Repeat dose - 7 days<br> | Drug: ETD002 - 7 day repeat dose<br>* Twice daily doses of ETD002 for 7 days<br>Drug: Placebo - 7 day repeat dose<br>* Twice daily doses of Placebo for 7 days<br>|
| Experimental: Repeat dose - 14 days<br> | Drug: ETD002 - 14 day repeat dose<br>* Twice daily doses of ETD002 for 14 days<br>Drug: Placebo - 14 day repeat dose<br>* Twice daily doses of Placebo for 14 days<br>|
| Experimental: Repeat dose - 7 days with SABA<br> | Drug: ETD002 - 7 day repeat dose<br>* Twice daily doses of ETD002 for 7 days<br>Drug: Placebo - 7 day repeat dose<br>* Twice daily doses of Placebo for 7 days<br>Drug: Salbutamol<br>* Twice daily doses of salbutamol for 3 days (Days 5, 6 & 7)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting one or more treatment emergent adverse event (TEAE) |  | Baseline to Week 8 | 
| Number of participants who discontinue due to an adverse event (AE) |  | Baseline to Week 8 | 
| Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose |  | Baseline to Week 8 | 
| Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose |  | Baseline to Week 8 | 
| Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose |  | Baseline to Week 8 | 
| Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose |  | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of ETD002 | Blood levels of ETD002 measured after dosing | Day 1 pre-dose and at multiple time points (up to 14 days) post final dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic fibrosis