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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN15391202 | Other Identifier | ISRCTN |
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This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and target engagement of ETH47 in healthy participants following single intranasal and single inhaled administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A-1 | Experimental |
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| Part A-2 | Experimental |
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| Part A-3 | Experimental |
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| Part A-4 | Experimental |
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| Part A-5 | Experimental |
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| Part B-1 | Experimental |
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| Part B-2 | Experimental |
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| Part B-3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETH47 | Drug | Dose level 1; single intranasal administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events (TEAEs) | From treatment until end of study (d 21) | |
| Number of serious adverse events (SAEs) | From enrollment until end of study (day 21) |
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Inclusion Criteria:
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF), restriction handbook and in this protocol.
Participants who are overtly healthy, as determined by screening assessments and the Investigator's judgement, aged ≥18 and ≤55 years at the time of obtaining informed consent.
Body mass index of 18.5 to 32 kg/m2 (inclusive).
Participants must agree to use contraception methods.
Parts B only: participants must be able to perform reliable and reproducible pulmonary function tests and meet the following criteria at screening:
Major Exclusion Criteria:
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, or immunosuppressive disorders which, in the Investigator's judgement, puts the participant at risk due to participation in the trial, may influence the results of the trial, or the subject's ability to participate in the trial.
Signs or symptoms of upper or lower respiratory tract infection within 2 weeks of randomisation.
Participants who are SARS-CoV-2 positive.
Known or positive laboratory results at screening for human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C.
Any malignancy except for the following:
The evidence of any other active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, haematology, blood chemistry, serology, and urinalysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRO | Merthyr Tydfil | United Kingdom |
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| Part B-4 | Experimental |
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| ETH47 |
| Drug |
Dose level 2; single intranasal administration |
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| ETH47 | Drug | Dose level 3; single intranasal administration |
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| ETH47 | Drug | Dose level 4; single intranasal administration |
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| ETH47 | Drug | Dose level 5; single intranasal administration |
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| ETH47 | Drug | Dose level 1; single inhaled administration |
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| ETH47 | Drug | Dose level 2; single inhaled administration |
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| ETH47 | Drug | Dose level 3; single inhaled administration |
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| ETH47 | Drug | Dose level 4; single inhaled administration |
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