Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Ascending Doses in Healthy Participants
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, First-in-Human study in healthy participants, performed at a single study
      center, consisting of 2 parts: Part 1 is a single ascending dose (SAD) study and Part 2 is a
      multiple ascending dose (MAD) study.
    

Detailed description: 
      Part 1: This is a double-blind, randomized, placebo-controlled study consisting of 2 parts.
      Part 1: SAD and Part 2: MAD.

      Part 1 will be a double-blind, randomized, placebo-controlled study, with a sequential SAD
      design. Three dose levels of AZD5055 are planned to be investigated in 3 cohorts. Depending
      on evaluation of data from the preceding cohorts, 2 additional cohorts/dose levels may be
      added at the discretion of the SRC.

      Part 1 will comprise of:

        -  A Screening Period of a maximum of 6 weeks.

        -  A Treatment Period during which subjects will be resident at the Clinical Unit from 1
           day before IMP administration (Day 1) until at least 72 hours after IMP administration
           (Day 4). Subjects will receive a single oral dose of AZD5055 or placebo on Day 1.

        -  A Follow up Visit within 6 ± 1 day after the IMP dose.

      Part 2 will be a double-blind, randomized, placebo-controlled study with a MAD design.
      Subjects will receive AZD5055 on Day 1 and Day 3 to Day 16, with no dosing on Day 2. Subjects
      will be naïve, ie, will not have participated in Part 1 of this study. Three dose levels of
      AZD5055 are planned to be investigated in 3 cohorts. Depending on evaluation of data of the
      preceding cohorts, up to 2 additional dose levels/cohorts may be added or expanded at the
      discretion of the SRC.

      Part 2 will comprise of:

        -  A Screening Period of a maximum of 6 weeks.

        -  A treatment period with a dosing frequency (QD or BID) that will be dependent on
           emerging PK data from Part 1:

      A) For cohorts with QD dosing regimens:

      • A Treatment Period during which subjects will be resident at the Clinical Unit from 1 day
      before IMP administration (Day -1) until at least 72 hours after the last dose given on Day
      16 (Day 19). Subjects will be dosed for a total of 15 days, receiving a single QD morning
      dose of AZD5055 or placebo on Day 1 and on Days 3 through Day 16.

      B) For cohorts with BID dosing regimens:

        -  A Treatment Period during which subjects will be resident at the Clinical Unit from 1
           day before IMP administration (Day -1) until at least 72 hours after the last dose given
           on Day 16 (Day 19). Subjects will be dosed for a total of 15 days, receiving a single
           morning dose of AZD5055 or placebo on Day 1 and Day 16, and repeated BID dosing on Day 3
           through Day 15, 12 hours (± 30 minutes) apart.

        -  A Follow-up Visit within 6 ± 1 day after the last IMP dose, and an additional Follow up
           Visit within 29 ± 2 days after the last IMP dose.
    

Intervention name(s): AZD5055; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Healthy participants will receive AZD5055; Healthy participants will receive placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AZD5055; Single ascending dose; Multiple ascending dose; Porcupine (PORCN) inhibitor; Healthy participants; Oral suspension