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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02654626

Run by

KBP Biosciences

People needed

16

Starts

2015-10-01

Expected to finish

2015-12-01

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Frontage Laboratories, Inc. — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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