Healthy
Conditions
Keywords
Phase 1, healthy male volunteers, dose escalation, pharmacokinetics, Single Ascending Dose, AZD2820 Cmax, tmax, t1/2λz
Brief summary
This is a randomised, single-blind, placebo-controlled Phase I study to investigate the safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to healthy male subjects.
Interventions
DRUGAZD2820
Subcutaneous Injection in abdomen or Thigh
DRUGPlacebo
Subcutaneous Injection in abdomen or Thigh
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy male subjects aged ≥20 - ≤45 years with suitable veins for cannulation or repeated venepuncture. * Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product. * Have a body mass index (BMI) between≥ 18 and ≤30 kg/m2 and weigh at least 50 kg and no more than 100 kg. * Provision of signed, written and dated informed consent for genetic research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
Exclusion criteria
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function * Predisposition or history of priapism (eg, sickle cell anemia or trait). * Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.) | Assessments performed multilpe times from the morning day 1 before dose until day 3. And then once at the follow up after 14-18 days |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics of AZD2820 and assess the dose proportionality of the pharmacokinetics following single ascending doses of AZD2820 by assessment Cmax, tmax, t1/2 , AUC, CL/F, Ae and CLR. | Blood samples will be taken multiple times from the morning day 1 before dose until day 2 |
Countries
United Kingdom
Outcome results
None listed