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A Study of AZD4205 in Healthy Adult Subjects (JACKPOT2)

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ClinicalTrials.gov Identifier: NCT03728023
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD4205 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: AZD4205
Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days
Drug: AZD4205
SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days

Placebo Comparator: Placebo
placebo single dose in SAD and once daily for 14 days
Drug: Placebo
Single dose in SAD and once daily for 14 days




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Female and/or male aged ≥18 ~ ≤ 45 years, with BMI ≥18~≤ 28kg/m2.
  3. 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.
  4. 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:

  1. 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.
  2. Infections
  3. Received a live vaccine within 3 months before first dose of IP.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728023


Contacts
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Contact: Lily Li +8618621629597 lily.li@dizalpharma.com
Contact: Pamela Yang +8613761961195 pamela.yang@dizalpharma.com

Locations
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United States, New Jersey
Frontage clinical service Recruiting
Secaucus, New Jersey, United States, 07094
Contact: Gregory J Tracey, MD         
Sponsors and Collaborators
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Gregory J Tracey Frontage Clinical Services, Inc.

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Responsible Party: Dizal (Jiangsu) Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03728023     History of Changes
Other Study ID Numbers: DZ2018J0001
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No