A Study of AZD4205 in Healthy Adult Subjects

Healthy Volunteers Clinical Trial

— JACKPOT2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728023
• Other study ID #: DZ2018J0001
• Status: Completed
• Phase: Phase 1
• Start date: November 12, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: April 2019
• Source: Dizal Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD4205
SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days
• Placebo
Single dose in SAD and once daily for 14 days

Locations

Country	Name	City	State
United States	Frontage clinical service	Secaucus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Dizal Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects with adverse events	To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs)	From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
Primary	The number of subjects with abnormal laboratory parameters	To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters	From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
Primary	The number of subjects with abnormal vital signs	To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs	From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)
Primary	The number of subjects with abnormal electrocardiogram	To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram	From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)