Chronic PainPhase 1NCT05714254
Multiple Dose Study of Safety 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 single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers. Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MEDI0618
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 12 Dec 2022to 12 Dec 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longer
- Donation of blood or plasma within 2 months prior to screening and until after the final follow-up visit
- Poor venous access
- History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologics
- Prescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or disorder
- History of cancer within 5 years of screening
Show all 9Show fewer
- History of drug abuse
- Use of prescriptions or non-prescription medicines within 7 days or 5 half-lives, whichever is longer, prior to administration of study treatments
- Any clinical abnormality on complete physical examination, vitals signs, ECG or clinical laboratory test results at screening or between screening and randomisation
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 Multiple Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers
This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers.
Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection.
Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.
- Conditions
- Chronic Pain
- Being tested
- MEDI0618, Placebo
- 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
Also called Protease-Activated Receptor 2 Antagonist
Four doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks.
PlaceboDrug
Four doses of IV placebo or SC placebo administered once every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| MEDI0618 | Active comparator | A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2) Receives: Drug: MEDI0618 |
| Placebo | Placebo comparator | Histidine/histidine HCl, sucrose and polysorbate Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Measured: From Screening, Day 1 to Day 113
Incidence of abnormal vital signs
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Measured: From Screening, Day 1 to Day 113
Incidence of abnormal laboratory parameters
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Measured: Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
Secondary outcomes (6)
Time to maximum observed plasma concentration (Tmax) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Measured: Day 1 to Day 113
Maximum observed plasma concentration (Cmax) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Measured: Day 1 to Day 113
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Measured: Day 1 to Day 113
Pre-dose trough concentration (Ctrough) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Measured: Day 1 to Day 113
The volume of plasma cleared of drug per unit time (CL) of MEDI0618
To characterise the pharmacokinetic (PK) profile of MEDI0618 administered IV or SC
Measured: Day 1 to Day 113
Anti-drug antibodies (ADA)
To characterise the immunogenicity of MEDI0618 administered IV or SC
Measured: Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start12 Dec 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stanislav Ignatenko, Principal investigator, Charite Research Organisation, Berlin Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714254
- Sponsor's protocol ID
- D7060C00002
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. 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 Multiple Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT05714254
- Acronym / sponsor ID
- D7060C00002
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 6 Feb 2023 (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 single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers.
Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection.
Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Protocol designed to evaluate safety, tolerability and pharmacokinetic profile of an intervention for treating chronic pain
| Arm | Type | Receives |
|---|---|---|
| MEDI0618 | Active comparator | Drug: MEDI0618A human immunoglobulin antibody to the Protease Activated Receptor 2 (PAR2) |
| Placebo | Placebo comparator | Drug: PlaceboHistidine/histidine HCl, sucrose and polysorbate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longer
- Donation of blood or plasma within 2 months prior to screening and until after the final follow-up visit
- Poor venous access
- History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologics
- Prescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or 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 |
|---|---|---|
| MEDI0618Also: Protease-Activated Receptor 2 AntagonistFour doses of 100 mg IV, 200 mg IV or 200 mg SC MEDI0618 administered once every two weeks. | Drug | MEDI0618 |
| PlaceboFour doses of IV placebo or SC placebo administered once every two weeks. | Drug | Placebo |
Primary outcome
Incidence of adverse events
Time frame: From Screening, Day 1 to Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Incidence of abnormal vital signs
Time frame: From Screening, Day 1 to Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
Incidence of abnormal laboratory parameters
Time frame: Day -1, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
To characterise the safety and tolerability of MEDI0618 administered IV or SC
6 secondary outcomes
Time to maximum observed plasma concentration (Tmax) of MEDI0618
Time frame: Day 1 to Day 113
Maximum observed plasma concentration (Cmax) of MEDI0618
Time frame: Day 1 to Day 113
Area under plasma concentration-time curve over dosing interval (AUC[tau]) of MEDI0618
Time frame: Day 1 to Day 113
Pre-dose trough concentration (Ctrough) of MEDI0618
Time frame: Day 1 to Day 113
The volume of plasma cleared of drug per unit time (CL) of MEDI0618
Time frame: Day 1 to Day 113
Anti-drug antibodies (ADA)
Time frame: Day 1, Day 8, Day 29, Day 43, Day 57, Day 71, Day 99, Day 113
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 5 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Stanislav Ignatenko principal investigator
Charite Research Organisation, Berlin Germany
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 6 inclusion and 9 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 5 Jan 2024. 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. Some participants in this study may receive a placebo. 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 adverse events (time frame: From Screening, Day 1 to Day 113). The study lists 3 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 5 Jan 2024.