Clinical trial NCT04198558: A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Keywords: Double-blind
Placebo-controlled
Safety and Tolerability Study
Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 85 days
measure: Incidence of Treatment-Emergent Serious Adverse Events
timeFrame: Up to 85 days
measure: Vital Signs
timeFrame: Up to 85 days
measure: Vital Signs
timeFrame: Up to 85 days
measure: Body Weight
timeFrame: Up to 85 days
measure: Height
timeFrame: Up to 85 days
measure: Clinical Chemistry
timeFrame: Up to 85 days
measure: Haematology
timeFrame: Up to 85 days
measure: Thyroid Function
timeFrame: Up to 85 days
measure: Renal Function
timeFrame: Up to 85 days
measure: Urinalysis
timeFrame: Up to 85 days
measure: 12-Lead Electrocardiogram
timeFrame: Up to 85 days
measure: Physical Examination
timeFrame: Up to 85 days
Secondary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: Up to 85 days
measure: Time to maximum concentration (tmax)
timeFrame: Up to 85 days
measure: Area under the concentration versus time curve (AUC)
timeFrame: Up to 85 days
measure: Terminal half-life
timeFrame: Up to 85 days
measure: Bioavailability
timeFrame: Up to 85 days
Other outcomes:
measure: Anti-drug antibody incidence and titres
timeFrame: Up to 85 days
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tharani Chessell, PhD
role: STUDY_DIRECTOR
affiliation: Charite Research Organisation
name: Stanislav Ignatenko, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: