Chronic PainPhase 1NCT04198558
A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
A Phase 1 study testing MEDI0618 in people with Chronic Pain, run by AstraZeneca at 1 site in Germany.
Trial summary
This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MEDI0618
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 29 Nov 2019to 23 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a randomised, placebo-controlled study of the safety and tolerability of single doses of MEDI0618 in healthy volunteer subjects.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- MEDI0618, Placebo
- Keywords
- Double-blind, Placebo-controlled, Safety and Tolerability Study, Healthy Volunteers
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0618Drug
MEDI0618 A novel human immunoglobulin antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 2 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 3 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 4 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 5 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 6 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 7 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 8 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
| Dose Level 9 | Experimental | MEDI0618 or placebo Receives: Drug: MEDI0618; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events
Measured: Up to 85 days
Incidence of Treatment-Emergent Serious Adverse Events
Serious Adverse Events
Measured: Up to 85 days
Vital Signs
Heart Rate in beats per minute
Measured: Up to 85 days
Vital Signs
Blood pressure in mm Hg
Measured: Up to 85 days
Body Weight
Weight in kg
Measured: Up to 85 days
Height
Height in meters Height and weight will be combined to report BMI in kg/m^2
Measured: Up to 85 days
Clinical Chemistry
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
Measured: Up to 85 days
Haematology
Measurement of Haemoglobin, Haematocrit, Leukocyte count, Platelet count, Erythrocyte count, Reticulocyte count, Mean corpuscular haemoglobin
Measured: Up to 85 days
Thyroid Function
Measurement of Thyroid-stimulating hormone and free thyroxine
Measured: Up to 85 days
Renal Function
Measurement of Glomerular filtration rate
Measured: Up to 85 days
Urinalysis
Measurement of Haemoglobin, Leukocytes, Glucose, Protein and Creatinine
Measured: Up to 85 days
12-Lead Electrocardiogram
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Measured: Up to 85 days
Physical Examination
General physical examination
Measured: Up to 85 days
Secondary outcomes (5)
Peak plasma concentration (Cmax)
Peak concentration of MEDI0618 in plasma
Measured: Up to 85 days
Time to maximum concentration (tmax)
Time to maximum concentration of MEDI0618 in plasma
Measured: Up to 85 days
Area under the concentration versus time curve (AUC)
Calculated area under the concentration versus time curve for MEDI0618
Measured: Up to 85 days
Terminal half-life
Time required for the plasma concentration of MEDI0618 to decrease by 50%
Measured: Up to 85 days
Bioavailability
The fraction of MEDI0618 administered that is available to the systemic circulation
Measured: Up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start29 Nov 2019
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tharani Chessell, PhD, Study director, AstraZenecaStanislav Ignatenko, Medical Doctor, Principal investigator, Charite Research Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198558
- Sponsor's protocol ID
- D7060C00001
- Other IDs
- 2019-002128-33, 2019
- Status last verified
- Oct 2023
- First submitted
- 25 Nov 2019
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual patient-level data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04198558
- Acronym / sponsor ID
- D7060C00001
- Conditions
- Chronic Pain
- Keywords
- Double-blind, Placebo-controlled, Safety and Tolerability Study, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 2 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 3 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 4 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 5 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 6 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 7 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 8 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
| Dose Level 9 | Experimental | Drug: MEDI0618, Drug: PlaceboMEDI0618 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI0618MEDI0618 A novel human immunoglobulin antibody | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8, Dose Level 9 |
| PlaceboPlacebo | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8, Dose Level 9 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 85 days
Adverse Events
Incidence of Treatment-Emergent Serious Adverse Events
Time frame: Up to 85 days
Serious Adverse Events
Vital Signs
Time frame: Up to 85 days
Heart Rate in beats per minute
Vital Signs
Time frame: Up to 85 days
Blood pressure in mm Hg
Body Weight
Time frame: Up to 85 days
Weight in kg
Height
Time frame: Up to 85 days
Height in meters Height and weight will be combined to report BMI in kg/m^2
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
12-Lead Electrocardiogram
Time frame: Up to 85 days
Measurement of Heart rate; PR, QRS, RR, QT and QTc intervals from digital recordings
Physical Examination
Time frame: Up to 85 days
General physical examination
5 secondary outcomes
Peak plasma concentration (Cmax)
Time frame: Up to 85 days
Time to maximum concentration (tmax)
Time frame: Up to 85 days
Area under the concentration versus time curve (AUC)
Time frame: Up to 85 days
Terminal half-life
Time frame: Up to 85 days
Bioavailability
Time frame: Up to 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- CSR SYNOPSISLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised individual patient-level data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tharani Chessell, PhD study director
AstraZeneca
Stanislav Ignatenko, Medical Doctor principal investigator
Charite Research Organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI0618 in people with Chronic Pain, run by AstraZeneca at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 85 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.