A Study of AZD4205 in Healthy Adult Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT03728023
- Run by
- Dizal Pharmaceuticals
- People needed
- 66
- Starts
- 2018-11-12
- Expected to finish
- 2019-08-20
- Last updated by the study team
- 2020-08-24
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Frontage clinical service — Secaucus, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.