A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT05384262
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AZD0780 — DRUG
    Subjects will receive AZD0780 orally as a single ascending dose.
  • AZD0780 — DRUG
    Subjects will receive AZD0780 orally as a multiple ascending dose.
  • AZD0780 — DRUG
    Subjects will receive AZD0780 orally as a single and multiple ascending dose.
  • Placebo — DRUG
    Subjects will receive placebo matching the AZD0780 dose orally as a single ascending dose.
  • Placebo — DRUG
    Subjects will receive placebo matching the AZD0780 dose orally as a multiple ascending dose.
  • Placebo — DRUG
    Subjects will receive placebo matching the AZD0780 dose orally as a single and multiple ascending dose.
  • Rosuvastatin — DRUG
    Subjects will receive rosuvastatin orally.

Study Details

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels. This study will consist of two parts (Parts A and B). 56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.

Key Dates

Start date
May 18, 2022
Status verified
Jul 2024
Primary completion
Jun 14, 2024
Completion
Jun 14, 2024

Study Design

Enrollment
183 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort 1: Part A1 - AZD0780 dose 1/placebo tablet
    A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
  • Active Comparator: Cohort 2: Part A1 - AZD0780 dose 2/placebo tablet
    A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
  • Active Comparator: Cohort 3: Part A1 - AZD0780 dose 3/placebo tablet
    A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
  • Active Comparator: Cohort 4: Part A1 - AZD0780 dose 4/placebo tablet
    A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
  • Active Comparator: Cohort 5: Part A1 - AZD0780 dose 5/placebo tablet
    A total of 6 subjects will receive single ascending doses of AZD0780 and 2 will receive placebo.
  • Active Comparator: Cohort 6: Part B - AZD0780 dose 6/placebo tablet
    A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
  • Active Comparator: Cohort 7: Part B - AZD0780 dose 7/placebo tablet
    A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
  • Active Comparator: Cohort 8: Part B - AZD0780 dose 8/placebo tablet
    A total of 20 subjects will be assigned as 3:1::AZD0780:Placebo to receive multiple ascending doses.
  • Active Comparator: Cohort 9: Part B - AZD0780 dose 9/placebo tablet
    A total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.
  • Active Comparator: Cohort 10: Part B - AZD0780 dose 10/placebo tablet
    A total of 6 subjects will receive single and multiple ascending doses of AZD0780 and 2 will receive placebo.
  • Active Comparator: Cohort 11: Part A2 - AZD0780 dose 11/placebo tablet
    A total of 5 subjects will receive single ascending doses of AZD0780 and placebo.
  • Active Comparator: Cohort 12: Part B - AZD0780 dose 1/rosuvastatin dose 12
    A total of 20 subjects will receive single dose of AZD0780 and rosuvastatin.
  • Active Comparator: Cohort 13: Part B - placebo tablet/rosuvastatin dose 12
    A total of 20 subjects will receive single dose of placebo and rosuvastatin.
  • Active Comparator: Cohort 14: Part B - AZD0780 with placebo tablet/AZD0780 with rosuvastatin dose 12
    A total of 20 subjects will receive AZD0780 in combination with rosuvastatin or 5 subjects will receive placebo in combination with rosuvastatin.

Primary Outcome Measure

Number of subjects with Adverse Events [ Time Frame: From Screening (≤ 28 days) until Follow-up Visit (5 to 7 days post-dose for all cohorts, and 9 to 11 days post-dose for subjects from Cohort 3 onwards) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBrooklynMaryland21225-

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By research site
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