A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects

Biogen

Status and phase: Completed; Phase 1

Conditions: Tauopathies

Treatments: Drug: BMS-986168; Drug: BMS-986168 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02294851

CN002-001

Details and patient eligibility

About

This is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.

Full description

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Enrollment: 65 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female subjects, who have no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
• Body Mass Index (BMI) of 18.5-30 kg/m^2, inclusive. BMI=weight (kg)/[height(m)]^2.
• Males and Females, not of child-bearing potential, ages 21 to 65 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential.
• Male subjects must be willing to use effective birth control and refrain from sperm donation during the entire study and for 200 days after dosing has been completed.

Exclusion criteria

• Women who are of childbearing potential or breastfeeding.
• Any significant acute or chronic medical illness.
• Any history of cancer within 5 years of enrollment.
• Any major surgery within 4 weeks of study drug administration.
• Donation of blood or serum > 500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration.
• Participation in a clinical study (except a screening visit) within 4 weeks (or 5 half lives, whichever is longer), of study drug administration.
• Inability to be venipunctured and/or tolerate venous access.
• Has smoked or used tobacco products within 6 months prior to study drug administration.
• Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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65 participants in 2 patient groups, including a placebo group

Single Ascending dose cohorts

Experimental group

Description:

Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.

Treatment:

Drug: BMS-986168

Placebo

Placebo Comparator group

Description:

BMS-986168 Placebo

Treatment:

Drug: BMS-986168 Placebo