A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects

KBP Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: KBP-7072; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02654626

KBP7072-1-002

Details and patient eligibility

About

This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subject
• Are between the ages of 18 and 55 years (inclusive);
• Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg.

Exclusion criteria

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
• Known or suspected malignancy;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody;
• Positive pregnancy test result.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 4 patient groups

KBP-7072: Cohort 1

Experimental group

Description:

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Treatment:

Drug: KBP-7072

Other: Placebo

KBP-7072: Cohort 2

Experimental group

Description:

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Treatment:

Drug: KBP-7072

Other: Placebo

KBP-7072: Cohort 3

Experimental group

Description:

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Treatment:

Drug: KBP-7072

Other: Placebo

KBP-7072: Cohort 4

Experimental group

Description:

Healthy Volunteers will receive multiple dose of KBP-7072 and placebo

Treatment:

Drug: KBP-7072

Other: Placebo