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| ID | Type | Description | Link |
|---|---|---|---|
| 1011367 | Other Identifier | IRAS ID |
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This is a two-part study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and receptor occupancy (RO) of ENX-205 in healthy adult participants in a double-blind placebo-controlled, single ascending dose (SAD) study (Part 1) and an open-label, single-dose, positron emission tomography (PET) study (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENX-205 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENX-205 | Drug | oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Treatment Emergent Adverse events | From Day 1 up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Number of Participants with Treatment Emergent Adverse events | From Day 1 up to Day 10 |
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Inclusion Criteria:
Biologically female participants who are not pregnant, lactating, or breastfeeding
Biologically male participants (defined as assigned male at birth), if fertile must be willing to comply with restrictions related to birth control. Moreover, male participants should refrain from sperm donation.
Exclusion Criteria:
• Unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study
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| Name | Affiliation | Role |
|---|---|---|
| David George Steel, MBChB | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel London EPCU | London | Middlesex | HA1 3UJ | United Kingdom |
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Part 2 of this study is open-label, and as such, randomization and blinding are not applicable.
| Drug |
oral solution |
|