A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04198558

Enrollment

Registered

2019-12-13

Start date

2019-11-29

Completion date

2022-02-23

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Double-blind, Placebo-controlled, Safety and Tolerability Study, Healthy Volunteers

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.

Interventions

DRUGMEDI0618

MEDI0618 A novel human immunoglobulin antibody

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Double-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 85 days	Adverse Events
Incidence of Treatment-Emergent Serious Adverse Events	Up to 85 days	Serious Adverse Events
Vital Signs	Up to 85 days	Heart Rate in beats per minute
Body Weight	Up to 85 days	Weight in kg
Height	Up to 85 days	Height in meters Height and weight will be combined to report BMI in kg/m\^2
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
12-Lead Electrocardiogram	Up to 85 days	Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Physical Examination	Up to 85 days	General physical examination

Secondary

Measure	Time frame	Description
Peak plasma concentration (Cmax)	Up to 85 days	Peak concentration of MEDI0618 in plasma
Time to maximum concentration (tmax)	Up to 85 days	Time to maximum concentration of MEDI0618 in plasma
Area under the concentration versus time curve (AUC)	Up to 85 days	Calculated area under the concentration versus time curve for MEDI0618
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

Other

Measure	Time frame	Description
Anti-drug antibody incidence and titres	Up to 85 days	Anti-drug (MEDI0618) antibody incidence and titres

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026