Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: BMS-986089; Drug: Placebo matching with BMS-986089

Study type: Interventional

Funder types: Industry

Identifiers

NCT02145234

CN001-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.

Full description

Primary Purpose - other: Protocol designed to assess the safety, tolerability, immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy subjects

Enrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96

Minimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD Panel 70 years of age)

Enrollment: 140 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
• Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years
• Women must not be breastfeeding
• Men who are sexually active with women of child bearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year

Exclusion Criteria:

• Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration
• Any condition that will clearly require medical or surgical treatment during the period of study participation
• Any bone trauma or bone surgery within 3 months of study drug administration
• Known or suspected autoimmune disorder
• Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

140 participants in 12 patient groups

SAD Panel 1:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

SAD Panel 2:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

SAD Panel 3:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

SAD Panel 4:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

SAD Panel 5:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

MAD Panel 1:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 multiple subcutaneous administrations weekly

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

MAD Panel 2:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

MAD Panel 3:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

MAD Panel 4:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

MAD Panel 5:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in multiple subcutaneous administration every 2 weeks OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

MAD Panel 6:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089

MAD Panel 7:BMS-986089/Placebo

Experimental group

Description:

BMS-986089 a single subcutaneous administrations weekly OR Placebo matching with BMS-986089 a single subcutaneous administration every 2 weeks

Treatment:

Drug: BMS-986089

Drug: Placebo matching with BMS-986089