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This study will assess the adverse events, tolerability, and how bretisilocin intramuscular (IM) Injection moves through the body of healthy adult Japanese, Han Chinese, and Non-Asian volunteers participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-Bretisilocin-Japanese | Experimental | Participants will receive bretisilocin intramuscular (IM) injection on day 1. |
|
| Group 1-Bretisilocin-Han Chinese | Experimental | Participants will receive bretisilocin intramuscular (IM) injection on day 1. |
|
| Group 1-Bretisilocin-Non-Asian | Experimental | Participants will receive bretisilocin intramuscular (IM) injection on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bretisilocin | Drug | Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately 32 days |
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Inclusion Criteria:
Group 1: Healthy adult Japanese male or female;
• Japanese participants must be first-generation Japanese of full Japanese parentage residing outside of Japan for less than 5 years.
Group 2: Healthy adult Han Chinese male or female
• Han Chinese participants must be first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years.
Group 3: Healthy adult male or female volunteers of African, European, or Latin American descent.
A condition of general good health, based upon the results of a medical history, physical and neurological examination, vital signs, laboratory profile and 12-lead ECG.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel Collaborative Neuroscience Research /ID# 281612 | Recruiting | Los Alamitos | California | 90720 | United States |
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