Study to Assess Drug Levels, Immune Response, Safety and Tolerability of BMS-986446 in Healthy Chinese Participants.

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to assess the drug levels, immune response, safety and tolerability of BMS-986446 in healthy Chinese participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants must be of Chinese ethnicity (both biological parents are ethnically Chinese).

Participants must be Healthy adult male and female (as assigned at birth and non-pregnant and non-nursing).

Participants must have BMI of 18.0 to 28.0 kg/m2.

Disqualifiers

Participants must not have general history of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated, or hematological disorder; allergic disease; metabolic disorder; cancer; or cirrhosis.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986446

    Drug

    Specified dose on specified days

  • Placebo

    Other intervention

    Specified dose on specified days

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: BMS-986446Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum observed plasma concentration (Cmax)

Time frame
Up to Day 85
2

Time of maximum observed plasma concentration (Tmax)

Time frame
Up to Day 85
3

Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]

Time frame
Up to Day 85
4

Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Time frame
Up to Day 85

Secondary outcomes

1

Number of participants with anti-drug antibody (ADA) formation

Time frame
Up to Day 85
2

Number of participants with adverse events (AEs)

Time frame
Up to approximately 85 days
3

Number of participants with vital sign abnormalities

Time frame
Up to approximately 85 days
4

Number of participants with 12-lead electrocardiogram (12-lead-ECG) abnormalities

Time frame
Up to approximately 85 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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