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

K

KBP Biosciences

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: KBP-7072

Study type

Interventional

Funder types

Industry

Identifiers

NCT04532957
KBP7072-1-003

Details and patient eligibility

About

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

Full description

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple oral dose study. Overall, a total of 24 subjects were studied in 3 groups (Groups 1 to 3); with each group consisting of 8 subjects (6 subjects receiving KBP-7072 and 2 subjects receiving placebo). Groups 1 and 2 evaluated 100 and 200 mg QD, respectively. The dose level of 150 mg QD evaluated in Group 3 was determined based on data obtained from Group 2 of this stud

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

24 participants in 3 patient groups

Group 1
Experimental group
Description:
Multiple doses 100mg Healthy subjects receive multiple doses of KBP-7072 (100mg) or Placebo (100mg) QD capsules daily for a total of 10 days
Treatment:
Drug: KBP-7072
Drug: Placebo
Group 2
Experimental group
Description:
Multiple doses 200mg Healthy subjects receive multiple doses of KBP-7072 (200mg) or Placebo (200mg) QD capsules daily for a total of 10 days
Treatment:
Drug: KBP-7072
Drug: Placebo
Group 3
Experimental group
Description:
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
Treatment:
Drug: KBP-7072
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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