Trial Outcomes & Findings for Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model (NCT NCT02371668)
NCT ID: NCT02371668
Last Updated: 2020-03-17
Results Overview
Area under the curve (AUC) calculated from quantitative real-time RT-PCR for influenza A taken from 3 time per day nasal swab collection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
3 times a day for 10 days
Results posted on
2020-03-17
Participant Flow
104 participants signed consent and were enrolled on the protocol. 91 participants were inoculated and randomized. 13 participants did not meet criteria for influenza challenge at Day 0.
Participant milestones
| Measure |
CR6261
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
42
|
|
Overall Study
COMPLETED
|
49
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model
Baseline characteristics by cohort
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 times a day for 10 daysPopulation: All participants who were challenged with H1N1 and received CR6261
Area under the curve (AUC) calculated from quantitative real-time RT-PCR for influenza A taken from 3 time per day nasal swab collection.
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Area Under the Curve (AUC) of Viral Shedding
|
48.56 ViralLoad(log(copies/ml))per time(hours)
Interval 8.0 to 209.68
|
25.53 ViralLoad(log(copies/ml))per time(hours)
Interval 5.0 to 159.78
|
SECONDARY outcome
Timeframe: Evaluated daily for 10 days + 8 weeks convalescent follow upPopulation: All participants who were challenged with H1N1 and received CR6261
Percentage of participants who experienced either viral shedding or symptoms + a four fold rise in convalescent HAI titer.
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Confirmed Influenza Infection
|
73 percentage of participants
|
88 percentage of participants
|
SECONDARY outcome
Timeframe: Evaluated for up to 2 monthsPopulation: All participants who were challenged with H1N1 and received CR6261
Duration in days viral shedding was detected after influenza challenge
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Days of Shedding
|
2 Days
Interval 1.0 to 4.0
|
2.5 Days
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Evaluated for up to 2 monthsPopulation: All participants who were challenged with H1N1 and received CR6261
Duration in days symptoms were experienced after influenza challenge
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Days of Symptoms
|
5 Days
Interval 3.0 to 7.0
|
6 Days
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: Evaluated daily for 10 daysPopulation: All participants who were challenged with H1N1 and received CR6261
Percentage of participants who experienced influenza symptoms and shedding
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Mild to Moderate Influenza Disease
|
53 Percentage of participants
|
69 Percentage of participants
|
SECONDARY outcome
Timeframe: Evaluated for up to 2 monthsPopulation: All participants who were challenged with H1N1 and received CR6261
Number of unique influenza symptoms experienced after influenza challenge
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Number of Symptoms
|
3 Symptoms
Interval 2.0 to 5.0
|
4 Symptoms
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Evaluated daily for 10 daysPopulation: All participants who were challenged with H1N1 and received CR6261
Percentage of participants who experienced influenza symptoms
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Symptoms
|
76 Percentage of participants
|
93 Percentage of participants
|
SECONDARY outcome
Timeframe: Evaluated from day 0 to day 8Population: All participants who were challenged with H1N1 and received CR6261
Objective symptoms score from patient directed FLUPRO questionnaire (inFLUenza Patient-Reported Outcome dairy) . The FLUPRO questionnaire uses a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. Total scores can range from 0 (symptom free) to 4 (maximum severity of symptoms). Daily scores (Day 0 - Day 8) are averaged to calculate a total score for each participant, then calculated the median total FLUPRO score for each arm.
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Total FLUPRO Score
|
0.038 Scores on a scale
Interval 0.0125 to 0.08438
|
0.057 Scores on a scale
Interval 0.04063 to 0.08438
|
SECONDARY outcome
Timeframe: Evaluated daily for 10 daysPopulation: All participants who were challenged with H1N1 and received CR6261
Percentage of participants who experienced influenza viral shedding
Outcome measures
| Measure |
CR6261
n=49 Participants
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 Participants
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Viral Shedding
|
67 Percentage of participants
|
74 Percentage of participants
|
Adverse Events
CR6261
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CR6261
n=49 participants at risk
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 participants at risk
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
Other adverse events
| Measure |
CR6261
n=49 participants at risk
CR6261, Investigational monoclonal antibody against influenza A viruses
|
Placebo Comparator
n=42 participants at risk
Placebo, 5% dextrose (D-glucose) water
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Cardiac disorders
Bradycardia
|
10.2%
5/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Cardiac disorders
Tachycardia
|
6.1%
3/49 • 70 days
|
14.3%
6/42 • 70 days
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Eye disorders
Eye pain
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Gastrointestinal disorders
Abdominal pain
|
20.4%
10/49 • 70 days
|
9.5%
4/42 • 70 days
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
6/49 • 70 days
|
9.5%
4/42 • 70 days
|
|
Gastrointestinal disorders
Nausea
|
14.3%
7/49 • 70 days
|
16.7%
7/42 • 70 days
|
|
Gastrointestinal disorders
Oral pain
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Gastrointestinal disorders
Toothache
|
4.1%
2/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
3/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
General disorders
Asthenia
|
4.1%
2/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
General disorders
Chills
|
8.2%
4/49 • 70 days
|
21.4%
9/42 • 70 days
|
|
General disorders
Fatigue
|
42.9%
21/49 • 70 days
|
42.9%
18/42 • 70 days
|
|
General disorders
Non-cardiac chest pain
|
12.2%
6/49 • 70 days
|
11.9%
5/42 • 70 days
|
|
General disorders
Pain
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
General disorders
Pyrexia
|
16.3%
8/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Infections and infestations
Acarodermatitis
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Infections and infestations
Conjunctivitis
|
16.3%
8/49 • 70 days
|
16.7%
7/42 • 70 days
|
|
Infections and infestations
Hordeolum
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Infections and infestations
Influenza
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Infections and infestations
Onychomycosis
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Infections and infestations
Rhinitis
|
63.3%
31/49 • 70 days
|
73.8%
31/42 • 70 days
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.1%
2/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.2%
4/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Investigations
Alanine aminotransferase increased
|
22.4%
11/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Investigations
Amylase increased
|
24.5%
12/49 • 70 days
|
23.8%
10/42 • 70 days
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
7/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/49 • 70 days
|
9.5%
4/42 • 70 days
|
|
Investigations
Blood calcium decreased
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Investigations
Blood creatine phosphokinase
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
Blood creatine phosphokinase increased
|
22.4%
11/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Investigations
Blood glucose increased
|
6.1%
3/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
Blood potassium decreased
|
6.1%
3/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Investigations
Blood sodium increased
|
6.1%
3/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Investigations
Blood urea increased
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
Haemoglobin decreased
|
49.0%
24/49 • 70 days
|
57.1%
24/42 • 70 days
|
|
Investigations
Lipase increased
|
20.4%
10/49 • 70 days
|
9.5%
4/42 • 70 days
|
|
Investigations
Lymphocyte count decreased
|
6.1%
3/49 • 70 days
|
16.7%
7/42 • 70 days
|
|
Investigations
Neutrophil count decreased
|
32.7%
16/49 • 70 days
|
26.2%
11/42 • 70 days
|
|
Investigations
Oxygen saturation abnormal
|
8.2%
4/49 • 70 days
|
11.9%
5/42 • 70 days
|
|
Investigations
Platelet count decreased
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
White blood cell count decreased
|
8.2%
4/49 • 70 days
|
9.5%
4/42 • 70 days
|
|
Investigations
White blood cell count increased
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Investigations
White blood cells urine positive
|
4.1%
2/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.4%
10/49 • 70 days
|
16.7%
7/42 • 70 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.2%
6/49 • 70 days
|
14.3%
6/42 • 70 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.1%
2/49 • 70 days
|
9.5%
4/42 • 70 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.4%
9/49 • 70 days
|
14.3%
6/42 • 70 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.2%
4/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
12.2%
6/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
5/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.5%
12/49 • 70 days
|
26.2%
11/42 • 70 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Nervous system disorders
Disturbance in attention
|
4.1%
2/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Nervous system disorders
Dizziness
|
8.2%
4/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Nervous system disorders
Headache
|
51.0%
25/49 • 70 days
|
57.1%
24/42 • 70 days
|
|
Nervous system disorders
Mental impairment
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Psychiatric disorders
Insomnia
|
16.3%
8/49 • 70 days
|
19.0%
8/42 • 70 days
|
|
Psychiatric disorders
Nightmare
|
8.2%
4/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Renal and urinary disorders
Haematuria
|
8.2%
4/49 • 70 days
|
11.9%
5/42 • 70 days
|
|
Renal and urinary disorders
Proteinuria
|
10.2%
5/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.4%
11/49 • 70 days
|
38.1%
16/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/49 • 70 days
|
7.1%
3/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
42.9%
21/49 • 70 days
|
54.8%
23/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
7/49 • 70 days
|
26.2%
11/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
44.9%
22/49 • 70 days
|
52.4%
22/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
8.2%
4/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.2%
5/49 • 70 days
|
16.7%
7/42 • 70 days
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
2/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Vascular disorders
Diastolic hypertension
|
8.2%
4/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Vascular disorders
Flushing
|
0.00%
0/49 • 70 days
|
2.4%
1/42 • 70 days
|
|
Vascular disorders
Hypertension
|
4.1%
2/49 • 70 days
|
0.00%
0/42 • 70 days
|
|
Vascular disorders
Hypotension
|
12.2%
6/49 • 70 days
|
4.8%
2/42 • 70 days
|
|
Vascular disorders
Systolic hypertension
|
16.3%
8/49 • 70 days
|
9.5%
4/42 • 70 days
|
Additional Information
Memoli, Matthew
National Institute of Allergy and Infectious Diseases
Phone: +1 301 443 5971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place