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

NCT04532957 | Completed Phase 1 FDA Drug

• 1 other identifier: KBP7072-1-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, placebo-controlled, multiple oral dose study to evaluate safety, tolerability, and pharmacokinetic of KBP-7072 in healthy subjects.

Conditions

Healthy

Keywords

KBP-7072; Multiple ascending dose; Healthy Subjects; Antibiotics; Tetracycline

Outcome Measures

Primary Outcomes (1)

• Safety of KBP-7072 by assessing the number and severity of adverse events, laboratory abnormalities, ECGs, vital signs, and physical examinations.

  Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examinations

  Day 1 - 10

Secondary Outcomes (7)

• Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast),

  Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.

• Pharmacokinetics Parameters: AUC over a dosing interval (AUC0-τ), from time zero to time of last quantifiable concentration (AUC0-tlast)

  Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.

• Pharmacokinetics Parameters: Maximum observed plasma concentration (Cmax)

  Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.

• Pharmacokinetics Parameters: time of the maximum observed plasma concentration (Tmax)

  Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.

• Pharmacokinetics Parameters: apparent terminal elimination half-life (t1/2)

  Day 1 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours postdose; on Days 4, 7, 8 and 9 predose and on Day 10 predose and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours postdose.

Study Arms (3)

Group 1

EXPERIMENTAL

Multiple doses 100mg Healthy subjects receive multiple doses of KBP-7072 (100mg) or Placebo (100mg) QD capsules daily for a total of 10 days

Drug: KBP-7072; Drug: Placebo

Group 2

EXPERIMENTAL

Multiple doses 200mg Healthy subjects receive multiple doses of KBP-7072 (200mg) or Placebo (200mg) QD capsules daily for a total of 10 days

Drug: KBP-7072; Drug: Placebo

Group 3

EXPERIMENTAL

Multiple doses dose tbd Healthy subjects receive multiple doses of KBP-7072 (tbd) or Placebo(tbd) QD capsules daily for a total of 10 days

Drug: KBP-7072; Drug: Placebo

Interventions

KBP-7072 DRUG

QD oral capsules

Group 1; Group 2; Group 3

Placebo DRUG

matching placebo capsules

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females of nonchildbearing potential or males, of any race, between 18 and 50 years of age, inclusive, at screening.
• Body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening.
• In good health, determined by no clinically significant findings from medical history, physical and ophthalmologic examinations, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check in as assessed by the investigator (or designee).
• Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy will not be allowed.
• Alanine aminotransferase or AST ≥ 1 × ULN. Assessments may be repeated once if outside the range at screening and/or check-in, at the discretion of the investigator.
• Fibroscan controlled attenuation parameter (CAP) \> 238 dB/m and vibration controlled transient elastography (VCTE) \> 7 kPa.

Sponsors & Collaborators

• KBP Biosciences: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

kbp-7072

Study Officials

• James McCabe, MD

  KBP Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: August 31, 2020
• Study Start: August 11, 2020
• Primary Completion: October 8, 2020
• Study Completion: October 15, 2020
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)