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A Phase 1/2a, First-in-human, Randomized, Double-blinded, Placebo-controlled, Dose-finding Study in Healthy Volunteers and Participants with Sickle Cell Disease to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability, pH and Food Effect, and Preliminary Efficacy of BMS-986470

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510283-12-00
Acronym
CA230-1019
Enrollment
6
Registered
2025-05-16
Start date
2025-06-12
Completion date
Unknown
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Brief summary

Incidence of adverse events (AEs), serious adverse events (SAEs), AEs meeting protocol-defined dose limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death.

Detailed description

A summary of the exposure levels of the study drug as well as changes in levels of different types of hemoglobin including fetal and sickle forms of hemoglobin., The study will also check whether other markers connected to sickle cell disease are improving

Interventions

DRUGN/A

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs meeting protocol-defined dose limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death.

Secondary

MeasureTime frame
A summary of the exposure levels of the study drug as well as changes in levels of different types of hemoglobin including fetal and sickle forms of hemoglobin., The study will also check whether other markers connected to sickle cell disease are improving

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026