Healthy VolunteersPhase 1NCT02394314
A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
A Phase 1 study testing MEDI0382 in people with Healthy Volunteers, run by MedImmune LLC at 1 site in Germany.
Trial summary
A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MEDI0382
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Aug 2015
- 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
- Healthy Volunteers, ages 18-45
- Must provide written informed consent
- BMI >22 and <30 kg/m2 and body weight >70kg
- Venous access suitable for multiple cannulations
- Vital signs within normal specified ranges
- Females must be non-lactating and non-childbearing potential
- Males must practice 2 effective contraceptive measures if sexually active
Who cannot join
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- History of cancer, with the exception of non-melanoma skin cancer
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
- Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
- Concurrent or previous use of a GLP-1 receptor agonist
Show all 11Show fewer
- Current or previous use of systemic corticosteroids within the past 28 days prior to screening
- Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
- Known or suspected history of alcohol or drug abuse within the past 3 years.
- Positive drug screen
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.
Read the detailed description
This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8 cohorts. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.
- Conditions
- Healthy Volunteers
- Being tested
- MEDI0382, Placebo
- Keywords
- MEDI0382, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0382Drug
MEDI0382 administered subcutaneously
PlaceboDrug
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administered subcutaneously Receives: Drug: Placebo |
| MEDI0382 | Experimental | MEDI0382 administered subcutaneously Receives: Drug: MEDI0382 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382
Treatment emergent adverse events (TEAEs) and serious adverse events (STEAEs)
Measured: 28 days post dosing
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
GI symptomatology (a composite of nausea and vomiting)
Measured: 28 days post dosing
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)
Measured: 28 days post dosing
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
Measured: 28 days post dosing
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
Measured: 28 days post dosing
Secondary outcomes (3)
Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)
This variable will be estimated for MEDI0382 where the data allow.
Measured: 72 hours postdose
Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)
This variable will be estimated for MEDI0382 where the data allow.
Measured: 72 hours post dose
Proportion of subjects with ADA to MEDI0382
This variable will be estimated for MEDI0382 where the data allow.
Measured: 28 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394314
- Sponsor's protocol ID
- D5670C00001
- Status last verified
- Sep 2015
- First submitted
- 26 Feb 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02394314
- Acronym / sponsor ID
- D5670C00001
- Conditions
- Healthy Volunteers
- Keywords
- MEDI0382, diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Mar 2015 (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.
A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.
Detailed description
This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8 cohorts. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously |
| MEDI0382 | Experimental | Drug: MEDI0382MEDI0382 administered subcutaneously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy Volunteers, ages 18-45
- Must provide written informed consent
- BMI >22 and <30 kg/m2 and body weight >70kg
- Venous access suitable for multiple cannulations
- Vital signs within normal specified ranges
Key exclusion criteria (11 listed)
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- History of cancer, with the exception of non-melanoma skin cancer
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
- Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
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 |
|---|---|---|
| MEDI0382MEDI0382 administered subcutaneously | Drug | MEDI0382 |
| PlaceboPlacebo administered subcutaneously | Drug | Placebo |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382
Time frame: 28 days post dosing
Treatment emergent adverse events (TEAEs) and serious adverse events (STEAEs)
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Time frame: 28 days post dosing
GI symptomatology (a composite of nausea and vomiting)
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Time frame: 28 days post dosing
Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Time frame: 28 days post dosing
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382
Time frame: 28 days post dosing
Clinical laboratory assessments (serum chemistry, hematology, urinalysis)
3 secondary outcomes
Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)
Time frame: 72 hours postdose
Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)
Time frame: 72 hours post dose
Proportion of subjects with ADA to MEDI0382
Time frame: 28 days post dose
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 9 Sep 2015.
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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.
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 MEDI0382 in people with Healthy Volunteers, run by MedImmune LLC 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 7 inclusion and 11 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 9 Sep 2015. 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?
Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382 (time frame: 28 days post dosing). The study lists 5 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 9 Sep 2015.