Trial Outcomes & Findings for A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers (NCT NCT01544361)
NCT ID: NCT01544361
Last Updated: 2014-07-23
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
125 participants
Primary outcome timeframe
Day 1 to Day 106
Results posted on
2014-07-23
Participant Flow
Out of 125 participants enrolled, 32 participants were randomized to treatment.
Participant milestones
| Measure |
Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 1 MG/KG
n=6 Participants
A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 3 MG/KG
n=6 Participants
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 10 MG/KG
n=6 Participants
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 20 MG/KG
n=6 Participants
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
TOTAL
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.3 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
28.5 Years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
36.5 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
28.0 Years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
42.8 Years
STANDARD_DEVIATION 4.0 • n=21 Participants
|
33.5 Years
STANDARD_DEVIATION 9.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 106Population: Safety population included all randomized participants who received MEDI7814 and had safety data available.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Outcome measures
| Measure |
Placebo
n=8 Participants
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 1 MG/KG
n=6 Participants
A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 3 MG/KG
n=6 Participants
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 10 MG/KG
n=6 Participants
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 20 MG/KG
n=6 Participants
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106Population: Analyses of PK was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.
Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, 29, 57, 85, and 106Population: Analyses of immunogenicity was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI7814, 1 MG/KG
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MEDI7814, 3 MG/KG
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MEDI7814, 10 MG/KG
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MEDI7814, 20 MG/KG
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=8 participants at risk
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 1 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 3 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 10 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 20 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
Other adverse events
| Measure |
Placebo
n=8 participants at risk
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 1 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 3 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 10 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
MEDI7814, 20 MG/KG
n=6 participants at risk
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
|
|---|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Eye disorders
Lacrimation increased
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
General disorders
Feeling hot
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 2 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Reproductive system and breast disorders
Menstruation irregular
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
0.00%
0/6 • Day 1 to Day 106
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 106
|
Additional Information
Joseph M. Parker, Director, Clinical Development
MedImmune, LLC.
Phone: 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER