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Completed

NCT Number: NCT03728023

A Study of AZD4205 in Healthy Adult Subjects

This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Frontage clinical service

Secaucus, New Jersey, 07094, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be able to understand the nature of the trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses.
  • Female and/or male aged ≥18 ~ ≤ 45 years, with BMI ≥18~≤ 28kg/m2.
  • Female subjects must have negative pregnancy tests at screening and check-in AND: have been surgically sterile OR post-menopausal OR, if of child-bearing potential, must be using an acceptable method of contraception.
  • Male subjects must be surgically sterile or using an acceptable method of contraception during the study and for 6 months after the last dose of AZD4205 or matching placebo to prevent pregnancy with a partner.

Exclusion criteria

  • Evidence or reported history of clinically significant hematological (absolute neutrophil count < 1.5 x 10^3/μL; platelet count < 100 x 10^3/μL; hemoglobin < 9 g/dL, INR > 1.5), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease determined by the investigator.
  • Infections
  • Received a live vaccine within 3 months before first dose of IP.

Treatment and study plan

AZD4205

Drug

SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days

Placebo

Drug

Single dose in SAD and once daily for 14 days

Primary outcomes

  1. The number of subjects with adverse events

    Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

    To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs)

  2. The number of subjects with abnormal laboratory parameters

    Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

    To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters

  3. The number of subjects with abnormal vital signs

    Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

    To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs

  4. The number of subjects with abnormal electrocardiogram

    Time frame: From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

    To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study title

A Phase I, Randomized, Double Blind, Placebo Controlled 2-Parts Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD4205 Following Single and Multiple Ascending Dose in Healthy Adult Subjects, and to Assess the Effect of Food on the Pharmacokinetics of AZD4205

Acronym: JACKPOT2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2018
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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