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
Overview
- Phase
- Phase 1
- Intervention
- MEDI0618
- Conditions
- Chronic Pain
- Sponsor
- AstraZeneca
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- 12-Lead Electrocardiogram
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Dose Level 1
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 1
MEDI0618 or placebo
Intervention: Placebo
Dose Level 2
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 2
MEDI0618 or placebo
Intervention: Placebo
Dose Level 3
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 3
MEDI0618 or placebo
Intervention: Placebo
Dose Level 4
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 4
MEDI0618 or placebo
Intervention: Placebo
Dose Level 5
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 5
MEDI0618 or placebo
Intervention: Placebo
Dose Level 6
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 6
MEDI0618 or placebo
Intervention: Placebo
Dose Level 7
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 7
MEDI0618 or placebo
Intervention: Placebo
Dose Level 8
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 8
MEDI0618 or placebo
Intervention: Placebo
Dose Level 9
MEDI0618 or placebo
Intervention: MEDI0618
Dose Level 9
MEDI0618 or placebo
Intervention: Placebo
Outcomes
Primary Outcomes
12-Lead Electrocardiogram
Time Frame: Up to 85 days
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Clinical Chemistry
Time Frame: 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
Time Frame: Up to 85 days
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Thyroid Function
Time Frame: Up to 85 days
Measurement of Thyroid-stimulating hormone and free thyroxine
Renal Function
Time Frame: Up to 85 days
Measurement of Glomerular filtration rate
Urinalysis
Time Frame: Up to 85 days
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Physical Examination
Time Frame: Up to 85 days
General physical examination
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 85 days
Adverse Events
Body Weight
Time Frame: Up to 85 days
Weight in kg
Incidence of Treatment-Emergent Serious Adverse Events
Time Frame: Up to 85 days
Serious Adverse Events
Vital Signs
Time Frame: Up to 85 days
Blood pressure in mm Hg
Height
Time Frame: Up to 85 days
Height in meters Height and weight will be combined to report BMI in kg/m\^2
Secondary Outcomes
- Time to maximum concentration (tmax)(Up to 85 days)
- Terminal half-life(Up to 85 days)
- Bioavailability(Up to 85 days)
- Area under the concentration versus time curve (AUC)(Up to 85 days)
- Peak plasma concentration (Cmax)(Up to 85 days)