Healthy VolunteerPhase 1NCT05070312
Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese Participants
A Phase 1 study testing MEDI3506 in people with Healthy Volunteer, run by AstraZeneca at 1 site in China.
Trial summary
This study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of investigational drug MEDI3506 with single dose in Healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MEDI3506
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2021to 7 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Aged 18 to 45 years (inclusive, at the time of signing the ICF).
- Healthy, non smoking Chinese participants. Definition of non-smoker: non-smoker for at least the past 12 months with pack history ≤5 pack years.
- Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
- Have a body mass index between 19 and 24 kg/m2 , inclusive.
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- Male and female.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from enrolment throughout the study until their final follow-up visit. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together. All women of child bearing potential must have a negative serum pregnancy test result at Visit 1.
- A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Highly effective birth control methods include: a vasectomised partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.
- Females not of childbearing potential who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment prior to the planned date of randomization and follicle stimulating hormone (FSH) levels in the postmenopausal range.
- Nonsterilised males who are sexually active with a female partner of childbearing potential must use condom and spermicide from enrolment through the study period until their final follow up visit. Because male condom and spermicide is not a highly effective contraception method, female partners of a male study participants must also use a highly effective method of contraception as defined above throughout this period.
Who cannot join
- Any active medical or psychiatric condition or other reason which, in the opinion of the investigator, may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study.
- Any clinically relevant abnormal findings on physical examination of the cardiovascular system including ECG and vital signs at screening, and Day 1(pre-dose):
- Abnormal vital signs, after 10 minutes supine rest (confirmed by 1 controlled measurement), defined as any of the following: i. Fever greater than 37.5℃ ii. SBP < 90 mmHg or ≥ 140 mmHg iii. DBP < 50 mmHg or ≥ 90 mmHg iv. Pulse < 45 or > 100 bpm b. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T wave morphology, or left ventricular hypertrophy.
- Any other clinically relevant abnormal findings on physical examination or laboratory testing including haematology, coagulation, clinical chemistry or urinalysis at screening or randomization, which in the opinion of the investigator may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study. Abnormal findings include, but are not limited to:
- Serum alanine transaminase' (ALT) or aspartate transaminase' (AST) > 2.0 × upper limit of normal (ULN) or total bilirubin (TBL) > 2 × ULN (unless due to Gilbert's disease) or evidence of chronic liver disease
- Total white blood cell count < 4,000 × 106/L
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- Neutrophil count < 1,500/mm3
- Platelet count < 100,000/mm3
- Haemoglobin < 110 g/L
- History or a reason to believe that a participant has a history of drug or alcohol abuse within the past 2 years prior to screening.
- Positive drugs of abuse (DOA) including morphine, methamphetamine, ketamine, marijuana, methylenedioxymethamphetamin, and alcohol (unless can be explained by the participant's medications).
- Major surgery within 8 weeks prior to screening, or planned inpatient surgery or hospitalization during the study period.
- Donation of blood or blood products in excess of 400 mL within 3 months prior to screening and until the end of the follow-up period [Day 113].
- Participants who have a positive test for, or have been treated for hepatitis B, hepatitis C, Syphilis or HIV. Regarding the hepatitis B testing (hepatitis B surface antigen [HBsAg], hepatitis B surface antibody [anti-HBs], hepatitis B core antibody [anti-HBc]), any of the following would exclude the participant from the study:
- Participants positive for HBsAg.
- Participants positive for anti-HBc. Participants with a history of hepatitis B vaccination without a history of Hepatitis B are permitted.
- Evidence of active or latent tuberculosis (TB):
- Positive diagnostic TB test during screening (defined as a positive interferon-gamma release assay [IGRA] test for TB at screening).
- Participants with an indeterminate IGRA should undergo repeat test and if still indeterminate may be enrolled only after treatment and subsequent negative IGRA.
- Evidence of active COVID-19 infection:
- Positive diagnostic COVID-19 PCR result Or
- Subject has severe COVID-19 infection as defined by positive COVID-19 PCR result and hospitalization or radiological evidence of pneumonia in the previous 6 months.
- Receiving any of the medications listed below:
- Any immunotherapy or immunosuppressive therapy (within 1 year prior to randomization).
- Chronic use of steroid medications.
- Investigational agents (within the last 3 months or at least 5 times the predicted half-life of the agent, whichever is greater).
- Marketed biologics, including omalizumab (within the last 3 months or at least 5 times the predicted half-life of the biologics, whichever is greater).
- Immunoglobulin or blood products (within 6 months prior or randomization).
- Live vaccines (until the end of the follow-up period [Day 113]).
- Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day 1).
- Concurrent enrolment in another clinical study involving an investigational treatment.
- Received administration of an investigational drug or participated in a device trial within 3 months and 5.5 half-lives, prior to screening (Visit 1).
- History or current diagnosis of cancer, with the exception of cancer treated with apparent success with curative therapy (response duration of > 5 years).
- History of an underlying condition that predisposes the participant to infections (e.g., history of splenectomy, known primary or secondary immune deficiency syndromes).
- History of Inflammatory Bowel Disease or microscopic colitis.
- A known history of severe reaction to any medication including biologic agents and human gamma globulin therapy.
- History of allogeneic bone marrow transplant.
- History of a viral, bacterial, or fungal significant infection (including unexplained diarrhea) within 4 weeks (28 days) prior to randomization (Day 1) or clinical suspicion of infection at the time of dosing.
- History of herpes zoster within 3 months prior to randomization (Day 1).
- Participants with recent (within 12 months) clinical history of infective hepatitis or unexplained jaundice.
- Participant is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
- Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-ascending Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of MEDI3506 in Healthy Chinese Participants
This study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of investigational drug MEDI3506 with single dose in Healthy Chinese participants.
Read the detailed description
A phase I, randomised, double-blind, placebo-controlled parallel-group study to evaluate the pharmacokinetics, immunogenicity, safety, and tolerability of single dose of MEDI3506 in healthy Chinese Participants
- Conditions
- Healthy Volunteer
- Being tested
- MEDI3506, Placebo
- Keywords
- MEDI3506, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI3506Biological
MEDI3506
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MEDI3506 dose 1 | Experimental | MEDI3506 dose1 Receives: Biological: MEDI3506 |
| MEDI3506 dose 2 | Experimental | MEDI3506 dose 2 Receives: Biological: MEDI3506 |
| Placebo | Placebo comparator | Placebo 2 mL and 4 mL Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
To assess the maximum plasma concentration of MEDI3506 after single subcutaneous administrations in healthy Chinese participants.
Measured: Day 1 to Day 113
Area under the serum concentration time curve to the infinite (AUC0-inf)
To assess the area under the serum concentration time curve from pre-dose until infinite after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Measured: Day 1 to Day 113
Area under the serum concentration time curve to the last observation(AUC0-t)
To assess the area under the serum concentration time curve from pre-dose until the last observation quantified after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Measured: Day 1 to Day 113
Terminal Elimination half-life (t1/2)
To assess the terminal elimination half-life after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Measured: Day 1 to Day 113
Apparent total body Clearance (CL/F)
To evaluate the apparent MEDI3506 total body clearance from serum after single subcutaneous administration of MEDI3506 in healthy Chinese participants
Measured: Day 1 to Day 113
Apparent volume of distribution based on terminal phase (Vz/F)
To assess the apparent volume of distribution of MEDI3506 after single subcutaneous administration of MEDI3506 in healthy Chinese participants
Measured: Day 1 to Day 113
Time to reach maximum observed concentration (tmax)
To assess the MEDI3506 time to reach peak serum concentration after single subcutaneous administration of MEDI3506 in healthy Chinese participants.
Measured: Day 1 to Day 113
Secondary outcomes (2)
Immunogenicity determined by prevalence of antidrug antibodies (ADA)
Immunogenicity prevalence measured as number of participants with ADA positive at baseline and/or post-baseline
Measured: Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113
Immunogenicity determined by incidence of ADA
Immunogenicity incidence measured as number of participants with positive treatment emergent ADA
Measured: Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start23 Aug 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070312
- Sponsor's protocol ID
- D9182C00002
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-ascending Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of MEDI3506 in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT05070312
- Acronym / sponsor ID
- D9182C00002
- Conditions
- Healthy Volunteer
- Keywords
- MEDI3506, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 7 Oct 2021 (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 study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of investigational drug MEDI3506 with single dose in Healthy Chinese participants.
Detailed description
A phase I, randomised, double-blind, placebo-controlled parallel-group study to evaluate the pharmacokinetics, immunogenicity, safety, and tolerability of single dose of MEDI3506 in healthy Chinese Participants
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MEDI3506 dose 1 | Experimental | Biological: MEDI3506MEDI3506 dose1 |
| MEDI3506 dose 2 | Experimental | Biological: MEDI3506MEDI3506 dose 2 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2 mL and 4 mL |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Aged 18 to 45 years (inclusive, at the time of signing the ICF).
- Healthy, non smoking Chinese participants. Definition of non-smoker: non-smoker for at least the past 12 months with pack history ≤5 pack years.
- Able and willing to comply with the requirements of the protocol and complete the study until the end of the safety follow up period.
Key exclusion criteria (42 listed)
- Any active medical or psychiatric condition or other reason which, in the opinion of the investigator, may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study.
- Any clinically relevant abnormal findings on physical examination of the cardiovascular system including ECG and vital signs at screening, and Day 1(pre-dose):
- Any other clinically relevant abnormal findings on physical examination or laboratory testing including haematology, coagulation, clinical chemistry or urinalysis at screening or randomization, which in the opinion of the investigator may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study. Abnormal findings include, but are not limited to:
- History or a reason to believe that a participant has a history of drug or alcohol abuse within the past 2 years prior to screening.
- Positive drugs of abuse (DOA) including morphine, methamphetamine, ketamine, marijuana, methylenedioxymethamphetamin, and alcohol (unless can be explained by the participant's medications).
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 |
|---|---|---|
| MEDI3506MEDI3506 | Biological | MEDI3506 dose 1, MEDI3506 dose 2 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Day 1 to Day 113
To assess the maximum plasma concentration of MEDI3506 after single subcutaneous administrations in healthy Chinese participants.
Area under the serum concentration time curve to the infinite (AUC0-inf)
Time frame: Day 1 to Day 113
To assess the area under the serum concentration time curve from pre-dose until infinite after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Area under the serum concentration time curve to the last observation(AUC0-t)
Time frame: Day 1 to Day 113
To assess the area under the serum concentration time curve from pre-dose until the last observation quantified after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Terminal Elimination half-life (t1/2)
Time frame: Day 1 to Day 113
To assess the terminal elimination half-life after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Apparent total body Clearance (CL/F)
Time frame: Day 1 to Day 113
To evaluate the apparent MEDI3506 total body clearance from serum after single subcutaneous administration of MEDI3506 in healthy Chinese participants
Apparent volume of distribution based on terminal phase (Vz/F)
Time frame: Day 1 to Day 113
To assess the apparent volume of distribution of MEDI3506 after single subcutaneous administration of MEDI3506 in healthy Chinese participants
Time to reach maximum observed concentration (tmax)
Time frame: Day 1 to Day 113
To assess the MEDI3506 time to reach peak serum concentration after single subcutaneous administration of MEDI3506 in healthy Chinese participants.
2 secondary outcomes
Immunogenicity determined by prevalence of antidrug antibodies (ADA)
Time frame: Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113
Immunogenicity determined by incidence of ADA
Time frame: Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and 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 25 Mar 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 MEDI3506 in people with Healthy Volunteer, run by AstraZeneca at 1 site in China.
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 11 inclusion and 42 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 25 Mar 2022. 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 China. 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?
Maximum observed concentration (Cmax) (time frame: Day 1 to Day 113). The study lists 7 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 25 Mar 2022.