Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074

NCT02228733 | Completed Phase 1

• 1 other identifier: KBP5074-1-001
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single ascending dose (SAD) study in healthy subjects will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. PK/PD (plasma aldosterone, serum potassium and urine albumin levels) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase 2 dose-finding study to evaluate the efficacy, safety and tolerability of KBP-5074 in patients that could slow the progression of nephropathy as well as control hypertension.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• The safety and tolerability

  Assessing the number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations): pre dose and post dose

  14 days

• Area Under Curve (AUC) Time Frame

  Assessing drug exposure across time. AUC is a useful metric when trying to determine whether two formulations of the same dose (for example a capsule and a tablet) result in equal amounts of tissue or plasma exposure. Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 168, 216, 264 and 312 hours post-dose

  14 days

Secondary Outcomes (2)

• The effect of food on Area Under Curve (AUC) Time Frame

  14 days

• The plasma aldosterone, serum potassium and urine albumin levels

  14 days

Study Arms (6)

KBP-5074: Cohort 1

EXPERIMENTAL

Healthy Volunteers will receive one dose of KBP-5074

Drug: KBP-5074

KBP-5074: Cohort 2

EXPERIMENTAL

Healthy Volunteers will receive one dose of KBP-5074

Drug: KBP-5074

KBP-5074: Cohort 3

EXPERIMENTAL

Healthy Volunteers will receive one dose of KBP-5074

Drug: KBP-5074

KBP-5074: Cohort 4

EXPERIMENTAL

Healthy Volunteers will receive one dose of KBP-5074

Drug: KBP-5074

KBP-5074: Cohort 5

EXPERIMENTAL

Healthy Volunteers will receive one dose of KBP-5074

Drug: KBP-5074

KBP-5074: Fed Group

EXPERIMENTAL

Healthy Volunteers will receive one dose of KBP-5074

Drug: KBP-5074

Interventions

KBP-5074 DRUG

Comparisons of different doses of study drug

KBP-5074: Cohort 1; KBP-5074: Cohort 2; KBP-5074: Cohort 3; KBP-5074: Cohort 4; KBP-5074: Cohort 5; KBP-5074: Fed Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2, no significant medical history, normal renal function and in good general health

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; A history of prescription drug abuse, or illicit drug use within 6 months prior to screening

Sponsors & Collaborators

• KBP Biosciences: lead

MeSH Terms

Interventions

KBP-5074

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 29, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 16, 2025

Record last verified: 2025-12