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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02654626

Enrollment

Registered

2016-01-13

Start date

2015-10-31

Completion date

2015-12-31

Last updated

2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGKBP-7072

Drug Intervention

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame	Description
Area Under Curve (AUC) in healthy subjects	up to 10 days	on Day 1 (first dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours post dose; on Days 4, 7, 8, and 9: pre-dose (within 30 minutes prior to dosing); on Day 10 (last dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026