HealthyPhase 1NCT01913028
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Single Administration in Healthy Male Japanese Subjects
A Phase 1 study testing MEDI9929 in people with Healthy, run by AstraZeneca at 2 sites in Japan.
Trial summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MEDI9929
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2013to Jan 2014
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy Japanese male subjects aged 20 - 45 years age with a body mass index(BMI) between 18 - 27 kg/m2 at the time of screening
- Sterilized males must be at least 1-year post vasectomy or non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85 (through Day 113 for cohort 3); It is highly recommended for both partners to use contraception, preferably one hormonal or intrauterine device (females) and one barrier method (males).
- Were men who agree to use birth control for 4 months after the last dose of investigational product and to not donate sperm for 4 months after the last dose of investigational product
- Able to comply with the requirements of the protocol
Who cannot join
- Had history or evidence of a clinically significant disorder, condition, or disease (including cardiopulmonary, oncologic, immunologic, autoimmune, collagen vascular, renal, metabolic, hematologic, or psychiatric), that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Any acute illness in the 14 days before Day 1
- Had evidence of any active or suspected bacterial, viral, fungal, or parasitic infections within the past 30 days before randomization (eg, common cold, viral syndrome, flu-like symptoms), or a high risk, in the opinion of the investigator, for parasitic disease
- Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator
- Has a history of anaphylaxis to another therapeutic monoclonal antibody or biologic therapy
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA
Fukuoka, Hakata, 810-0064
Research Site
Fukuoka
About this study
Official title: A Phase 1, Single Centre, Single-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Administration of Single Ascending Doses in Healthy Male Japanese Subjects
The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.
Read the detailed description
This is a Phase I, single centre, randomised, single-blind, placebo-controlled, single ascending dose parallel study in healthy male Japanese subjects. Up to 3 dose levels of MEDI9929 will be investigated.
Primary object is to assess the safety and tolerability of single ascending subcutaneous (SC) doses of MEDI9929 in healthy male Japanese subjects. Secondary objectives are to characterize the pharmacokinetics (PK) of MEDI9929 in healthy male Japanese subjects and to evaluate the immunogenicity (IM) of MEDI9929 in healthy male Japanese subjects.
Up to 24 healthy subjects aged 20 to 45 years will participate in a maximum of 3 cohorts.
Eight subjects will participate in each cohort. Subjects will be randomized in a 3:1 ratio (active: placebo) and will receive a single dose of either MEDI9929 or placebo. Each subject will only participate in one cohort.
The first cohort will receive Dose 1 MEDI9929 (n=6) or placebo (n=2), the second cohort will receive Dose 2 MEDI9929 (n=6) or placebo (n=2), and the third cohort will receive Dose 3 MEDI9929 (n=6) or placebo (n=2).
Following a screening period of a maximum of 28 days, subjects will stay at the study facility for eight nights starting from the day before dosing (Day -1) to Day 8. The follow up period after the dosing will be 84 days (112 days for cohort 3). Subjects will receive a single dose of MEDI9929 or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period.
- Conditions
- Healthy
- Being tested
- MEDI9929, Placebo
- Keywords
- safety, tolerability, pharmacokinetics,immunogenicity, MEDI9929, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI9929Drug
1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo
PlaceboDrug
1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo
| Study group | Role | What they receive |
|---|---|---|
| MEDI9929 | Experimental | Solution of MEDI9929, SC Receives: Drug: MEDI9929 |
| Placebo | Placebo comparator | Placebo solution for MEDI9929, SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the Safety and tolerability profile of MEDI9929
To investigate the safety and tolerability (Adverse events, blood pressure and pulse, Electrocardiogram, Body temperature, respiratory rate, Haematology, Clinical Chemistry, Urinalysis, and physical examination) of MEDI9929 following administration of single ascending doses.
Measured: 84 days for cohort 1/2, 112 days for cohort 3
Secondary outcomes (2)
Description of Pharmacokinetics profile for MEDI9929
To characterize the pharmacokinetics of MEDI9929 after single SC dose in healthy male Japanese subjects. Where possible, the following PK parameters will be determined: Apparent SC clearance [CL/F], apparent SC volume of distribution [Vz/F], maximum observed serum concentration, [Cmax], time at which maximum concentration is observed [tmax], area under the serum concentration time curve from time zero to infinity [AUC0-inf] and to last observation [AUC(0-t)], elimination half-life [t½, z]
Measured: 84 days for cohort 1/2, 112 days for cohort 3
Description of Immunogenicity profile for MEDI9929
Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI9929 in blood.
Measured: 84 days for cohort 1/2, 112 days for cohort 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
- Investigators
- Kei Sakamoto, MD, PhD, Principal investigator, Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913028
- Sponsor's protocol ID
- D5180C00003
- Status last verified
- Feb 2014
- First submitted
- 30 Jul 2013
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Centre, Single-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Administration of Single Ascending Doses in Healthy Male Japanese Subjects
- ClinicalTrials.gov ID
- NCT01913028
- Acronym / sponsor ID
- D5180C00003
- Conditions
- Healthy
- Keywords
- safety, tolerability, pharmacokinetics,immunogenicity, MEDI9929, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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.
The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.
Detailed description
This is a Phase I, single centre, randomised, single-blind, placebo-controlled, single ascending dose parallel study in healthy male Japanese subjects. Up to 3 dose levels of MEDI9929 will be investigated.
Primary object is to assess the safety and tolerability of single ascending subcutaneous (SC) doses of MEDI9929 in healthy male Japanese subjects. Secondary objectives are to characterize the pharmacokinetics (PK) of MEDI9929 in healthy male Japanese subjects and to evaluate the immunogenicity (IM) of MEDI9929 in healthy male Japanese subjects.
Up to 24 healthy subjects aged 20 to 45 years will participate in a maximum of 3 cohorts.
Eight subjects will participate in each cohort. Subjects will be randomized in a 3:1 ratio (active: placebo) and will receive a single dose of either MEDI9929 or placebo. Each subject will only participate in one cohort.
The first cohort will receive Dose 1 MEDI9929 (n=6) or placebo (n=2), the second cohort will receive Dose 2 MEDI9929 (n=6) or placebo (n=2), and the third cohort will receive Dose 3 MEDI9929 (n=6) or placebo (n=2).
Following a screening period of a maximum of 28 days, subjects will stay at the study facility for eight nights starting from the day before dosing (Day -1) to Day 8. The follow up period after the dosing will be 84 days (112 days for cohort 3). Subjects will receive a single dose of MEDI9929 or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDI9929 | Experimental | Drug: MEDI9929Solution of MEDI9929, SC |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution for MEDI9929, SC |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy Japanese male subjects aged 20 - 45 years age with a body mass index(BMI) between 18 - 27 kg/m2 at the time of screening
- Sterilized males must be at least 1-year post vasectomy or non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85 (through Day 113 for cohort 3); It is highly recommended for both partners to use contraception, preferably one hormonal or intrauterine device (females) and one barrier method (males).
- Were men who agree to use birth control for 4 months after the last dose of investigational product and to not donate sperm for 4 months after the last dose of investigational product
- Able to comply with the requirements of the protocol
Key exclusion criteria (5 listed)
- Had history or evidence of a clinically significant disorder, condition, or disease (including cardiopulmonary, oncologic, immunologic, autoimmune, collagen vascular, renal, metabolic, hematologic, or psychiatric), that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Any acute illness in the 14 days before Day 1
- Had evidence of any active or suspected bacterial, viral, fungal, or parasitic infections within the past 30 days before randomization (eg, common cold, viral syndrome, flu-like symptoms), or a high risk, in the opinion of the investigator, for parasitic disease
- Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator
- Has a history of anaphylaxis to another therapeutic monoclonal antibody or biologic therapy
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 |
|---|---|---|
| MEDI99291st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo | Drug | MEDI9929 |
| Placebo1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo | Drug | Placebo |
Primary outcome
Description of the Safety and tolerability profile of MEDI9929
Time frame: 84 days for cohort 1/2, 112 days for cohort 3
To investigate the safety and tolerability (Adverse events, blood pressure and pulse, Electrocardiogram, Body temperature, respiratory rate, Haematology, Clinical Chemistry, Urinalysis, and physical examination) of MEDI9929 following administration of single ascending doses.
2 secondary outcomes
Description of Pharmacokinetics profile for MEDI9929
Time frame: 84 days for cohort 1/2, 112 days for cohort 3
Description of Immunogenicity profile for MEDI9929
Time frame: 84 days for cohort 1/2, 112 days for cohort 3
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 12 Feb 2014.
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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.
Kei Sakamoto, MD, PhD principal investigator
Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI9929 in people with Healthy, run by AstraZeneca at 2 sites in Japan.
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 5 inclusion and 5 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 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Description of the Safety and tolerability profile of MEDI9929 (time frame: 84 days for cohort 1/2, 112 days for cohort 3). 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 12 Feb 2014; AzTrials last refreshed its copy on 30 Oct 2026.