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

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

1. Females of nonchildbearing potential or males, of any race, between 18 and 50 years of age, inclusive, at screening.
2. Body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening.
3. 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).
4. Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion criteria

1. 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).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. 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.
4. 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.
5. 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

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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