NCT04055168

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects

A Phase I Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 After Single Dosing to Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will be a randomized, single-blind, placebo-controlled, single-ascending dose (SAD), sequential group study. It is a SAD study in healthy Non-Asian subjects (Part 1) and healthy Japanese subjects (Part 2) to assess the safety and tolerability of AZD6615 and to characterize the pharmacokinetics (PK) of AZD6615.

Detailed description

This study part is planned to consist of 3 cohorts of Non-Asian subjects (Part 1) and 2 cohorts of Japanese subjects (Part 2). Part 2 will be initiated no earlier than after completion of the last Safety Review Committee (SRC) review in Part 1. Healthy male and/or female subjects aged 20 to 60 years will be included in both Parts 1 and 2 of the study. Female subjects must be of non-childbearing potential. Study Part 1 is planned to be conducted in 24 subjects but may be conducted in up to 40 subjects. Study Part 2 is planned to be conducted in 16 subjects but may be conducted in up to 32 subjects. Within each cohort of Parts 1 and 2, 6 subjects will be randomized to receive AZD6615 and 2 subjects will be randomized to receive placebo. Dosing and food intake should be supervised and documented by study staff when subjects are in the clinic. The study will comprise of: * A Screening Period of maximum 28 days. * A Dosing Session during which subjects will be resident at the Clinical Unit from the day before IMP administration (Day -1) until at least 78 hours after Investigational medicinal product (IMP) administration; discharged on Day 4. * A Follow-Up Period of 12 weeks that will consist of 6 Follow-Up Visits, for which the subjects will return to the Clinical Unit at 2, 4, 6, 8, 10, and 12 weeks post-dose. Within each cohort, site personnel remain blinded until the SRC meeting. Following review of the data, the SRC may also decide to adjust the following for subsequent cohorts: * The time window between the sentinel dose group and the main dose group in Part 1. * The length of the stay at the study site, the timing and number of assessments and/or samples. * The length of the follow-up period. * The length of the data collection period for the SRC review.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	AZD6615	AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.
DRUG	Placebo	Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.

Timeline

• Start date: 2019-07-24
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2019-08-13
• Last updated: 2020-12-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study