A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | October 2015 |
| End Date: | March 2016 |
| Contact: | Bin Zhang |
| Email: | b.zhang@kbpbiosciences.com |
| Phone: | 609-531-0889 |
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
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.
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.
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.
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