A Study of AZD4205 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: AZD4205

• Registration Number: NCT03728023
• Lead Sponsor: Dizal Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Study Start: 2018-11-12
• Status Verified: 2019-04
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo single dose in SAD and once daily for 14 days
AZD4205	AZD4205	Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days

Primary Outcome Measures

Name	Time	Method
The number of subjects with abnormal vital signs	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
The number of subjects with abnormal laboratory parameters	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
The number of subjects with adverse events	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)
The number of subjects with abnormal electrocardiogram	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

Trial Locations

Locations (1)

Frontage clinical service; 🇺🇸 Secaucus, New Jersey, United States