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NCT05507463 · ClinicalTrials.gov registry record · Phase 1

Study of KBP-7072 in Healthy Male and Female Subjects

A Phase 1 study of Healthy Subjects, sponsored by KBP Biosciences.

Completed
Registry status
Phase 1
Development phase
56
Enrollment target
1
Study location

NCT05507463 is a Phase 1 study of Healthy Subjects that has completed, run by KBP Biosciences. The registered enrollment target is 56 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05507463, a Phase 1 study of Healthy Subjects, has completed, sponsored by KBP Biosciences.

COMPLETED
Registry status
Phase 1
Development phase
56 participants
Enrollment target
1
Study location

Study Summary

This is a double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Subjects will reside at the study site from check-in on Day -1 (the day before dosing) to discharge on Day 8. In Part A, serial blood and urine collections will be obtained on Day 1 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings. Part B (MAD) will comprise an ascending multiple dose, sequential group study. Each subject will participate on one treatment period only and reside at the study site from check-in on Day -1 until discharge on Day 17. In Part B, serial blood and urine collections will be obtained on Day 1 pre-dose through 24 hours post start of infusion and on Day 10 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Trough blood sample collections for analysis of plasma concentrations of KBP-7072 and KBP-6079 will be obtained pre-dose on Days 3, 4, 5, 6, 7, 8 and 9. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings.

Conditions Studied

Healthy Subjects

Interventions

  • DRUG Placebo
  • DRUG KBP-7072

Study Locations (1)

Maryland

  • Parexel International - Early Phase Clinical Unit - Baltimore

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2022-08-16
Est. Completion 2023-06-29
Phase Phase 1

Sponsor

KBP Biosciences

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05507463

The ClinicalTrials.gov registry entry for NCT05507463 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (56% lower). The listed sponsor is KBP Biosciences, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05507463 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT05507463 about?

NCT05507463 is a clinical study titled "Study of KBP-7072 in Healthy Male and Female Subjects". This is a double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Subjects will reside at the study site from check-...

What is the current status of trial NCT05507463?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2022-08-16. Estimated completion is 2023-06-29.

What conditions does trial NCT05507463 study?

This clinical trial studies the following conditions: Healthy Subjects.

What interventions are being tested in trial NCT05507463?

The interventions under investigation include: Placebo (DRUG), KBP-7072 (DRUG).

Who is sponsoring clinical trial NCT05507463?

This trial is sponsored by KBP Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05507463 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.