A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
- Registration Number
- NCT04198558
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.
- Detailed Description
This is a randomised, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single ascending doses of MEDI0618 in healthy male and female volunteers.
This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo by intravenous administration, 1 cohort will receive MEDI0618 or placebo by subcutaneous administration.All subjects will undergo scheduled safety, tolerability, pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Healthy men and women of non-childbearing potential aged 18 to 55 years
- Normal 12-lead ECG at screening and on day of dosing
- Physical examinations with no significant findings at screening
- Be able to understand and comply with protocol requirements
- Participation in another clinical study with an investigational product (IP) within half-lives of the IP or 3 months, whichever is longer, prior to screening
- Requires treatment with another biological therapeutic agent
- Inability to comply with study-related requirements
- History of severe allergy or hypersensitivity reactions
- History of significant psychiatric disorder
- Presence of any clinically significant illness
- History of cancer
- Any clinically important abnormality physical examination, vital signs, ECG or laboratory test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose Level 3 Placebo MEDI0618 or placebo Dose Level 5 MEDI0618 MEDI0618 or placebo Dose Level 8 Placebo MEDI0618 or placebo Dose Level 2 Placebo MEDI0618 or placebo Dose Level 5 Placebo MEDI0618 or placebo Dose Level 6 Placebo MEDI0618 or placebo Dose Level 9 Placebo MEDI0618 or placebo Dose Level 1 MEDI0618 MEDI0618 or placebo Dose Level 1 Placebo MEDI0618 or placebo Dose Level 2 MEDI0618 MEDI0618 or placebo Dose Level 4 Placebo MEDI0618 or placebo Dose Level 6 MEDI0618 MEDI0618 or placebo Dose Level 7 MEDI0618 MEDI0618 or placebo Dose Level 3 MEDI0618 MEDI0618 or placebo Dose Level 7 Placebo MEDI0618 or placebo Dose Level 8 MEDI0618 MEDI0618 or placebo Dose Level 9 MEDI0618 MEDI0618 or placebo Dose Level 4 MEDI0618 MEDI0618 or placebo
- Primary Outcome Measures
Name Time Method 12-Lead Electrocardiogram Up to 85 days Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Clinical Chemistry Up to 85 days Measurement of Albumin, Protein, Aspartate transaminase, Alanine transaminase, Alkaline phosphatase, Bilirubin, Calcium, Creatine phosphokinase, C-reactive protein, Glucose, Blood urea nitrogen, Phosphate, Potassium, Sodium, Chloride and Bicarbonate
Haematology Up to 85 days Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Thyroid Function Up to 85 days Measurement of Thyroid-stimulating hormone and free thyroxine
Renal Function Up to 85 days Measurement of Glomerular filtration rate
Urinalysis Up to 85 days Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Physical Examination Up to 85 days General physical examination
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Up to 85 days Adverse Events
Body Weight Up to 85 days Weight in kg
Incidence of Treatment-Emergent Serious Adverse Events Up to 85 days Serious Adverse Events
Vital Signs Up to 85 days Blood pressure in mm Hg
Height Up to 85 days Height in meters Height and weight will be combined to report BMI in kg/m\^2
- Secondary Outcome Measures
Name Time Method Time to maximum concentration (tmax) Up to 85 days Time to maximum concentration of MEDI0618 in plasma
Terminal half-life Up to 85 days Time required for the plasma concentration of MEDI0618 to decrease by 50%
Bioavailability Up to 85 days The fraction of MEDI0618 administered that is available to the systemic circulation
Area under the concentration versus time curve (AUC) Up to 85 days Calculated area under the concentration versus time curve for MEDI0618
Peak plasma concentration (Cmax) Up to 85 days Peak concentration of MEDI0618 in plasma
Trial Locations
- Locations (1)
Research Site
🇩🇪Berlin, Germany