Healthy Participants Clinical Trial
Official title:
A Phase 1, Double-blinded, Randomized, Placebo-controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986454 in Healthy Participants
The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.
| Status | Recruiting |
| Enrollment | 56 |
| Est. completion date | December 12, 2024 |
| Est. primary completion date | December 12, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examinations, 12-lead ECGs, and clinical laboratory tests obtained during the screening period. - Participant is willing and able to adhere to the study visit schedule and other protocol requirements. - A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission. Exclusion Criteria: - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted. - Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer). - Inability to be venipunctured or tolerate venous access. Note: Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Local Institution - 0002 | London | Greater London |
| United Kingdom | Quotient Sciences Nottingham | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | Up to approximately 4 months | ||
| Primary | Number of participants with severe adverse events (SAEs) | Up to approximately 4 months | ||
| Primary | Number of participants with physical examination abnormalities | Up to approximately 4 months | ||
| Primary | Number of participants with vital sign abnormalities | Up to approximately 4 months | ||
| Primary | Number of participants with electrocardiogram (ECG) abnormalities | Up to approximately 4 months | ||
| Primary | Number of participants with clinical laboratory abnormalities | Up to approximately 4 months | ||
| Secondary | Maximum observed serum concentration (Cmax) | Up to approximately 3 months | ||
| Secondary | Time of maximum observed serum concentration (Tmax) | Up to approximately 3 months | ||
| Secondary | Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)] | Up to approximately 3 months | ||
| Secondary | Incidence of anti-drug antibody (ADA) formation | Up to approximately 3 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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