Clinical trial

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

Name

KBP7072-1-002

Description

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.

Trial arms

Trial start

2015-10-01

Estimated PCD

2015-12-01

Trial end

2015-12-01

Status

Completed

Phase

Early phase I

Treatment

KBP-7072

Drug Intervention

Arms:

KBP-7072: Cohort 1, KBP-7072: Cohort 2, KBP-7072: Cohort 3, KBP-7072: Cohort 4

Placebo

Arms:

KBP-7072: Cohort 1, KBP-7072: Cohort 2, KBP-7072: Cohort 3, KBP-7072: Cohort 4

Size

Primary endpoint

Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects

up to 17 days

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

Updated at

2024-02-23

1 organization

1 product

1 indication

Product

KBP-7072

Indication

Healthy

Organization

KBP Biosciences