Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI0618 · 2 trials · 1 indication
To characterise the safety and tolerability of MEDI0618 administered IV or SC
To characterise the safety and tolerability of MEDI0618 administered IV or SC
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Adverse Events
Serious Adverse Events
Heart Rate in beats per minute
Weight in kg
Height in meters Height and weight will be combined to report BMI in kg/m\^2
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
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Measurement of Thyroid-stimulating hormone and free thyroxine
Measurement of Glomerular filtration rate
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
General physical examination
| Arm | Type | Description |
|---|---|---|
| MEDI0618 | ACTIVE_COMPARATOR | A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2) |
| Placebo | PLACEBO_COMPARATOR | Histidine/histidine HCl, sucrose and polysorbate |
| Dose Level 1 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 2 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 3 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 4 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 5 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 6 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 7 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 8 | EXPERIMENTAL | MEDI0618 or placebo |
| Dose Level 9 | EXPERIMENTAL | MEDI0618 or placebo |
| Name | Type | Description |
|---|---|---|
| MEDI0618 | DRUG | Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks. |
| Placebo | DRUG | Four doses of IV placebo or SC placebo administered once every two weeks. |
Inclusion Criteria: * Healthy men and women of non-child bearing potential * Aged 18 to 50 years, inclusive * Weigh more than 50 kg * Body Mass Index between 18 to 30 kg/m2 * Healthy, in the opinion of the Principal Investigator * Able to understand and comply with the protocol requirements Exclus...
MEDI0618 is an investigational small molecule being developed for chronic pain. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics.
MEDI0618 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy volunteers.
MEDI0618 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not yet received regulatory approval for the treatment of chronic pain.
MEDI0618 has been studied in two completed Phase 1 trials. NCT04198558 evaluated safety, tolerability, and pharmacokinetics in 64 healthy volunteers in Germany. NCT05714254 was a multiple-dose study in 36 healthy volunteers in Germany. Both trials were placebo-controlled and double-blind.
MEDI0618 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for chronic pain. The completed trials have focused on safety and pharmacokinetics in healthy volunteers, and the drug has not yet progressed to later-stage efficacy studies.