Y242-01: Safety and Pharmacokinetic Study of Y242 in Adult Subjects

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT01515319
Collaborator
Medical Research Council (Other)
68
1
10
10.1
6.8

Study Details

Study Description

Brief Summary

Obesity causes 600 premature deaths per week in the UK and existing treatments are not effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as Peptide YY (PYY). The investigators have previously shown that injections of PYY reduce appetite and food intake in human volunteers. The investigators have now developed a very similar chemical, Y242, as a treatment for obesity. Y242 has been tested in animals and has been shown to be safe, to reduce their appetite, and to last for much longer than PYY itself. This study will test Y242 to ensure that it is well tolerated in humans, and to see how long it lasts in the blood stream after being injected under the skin. It will also look for any effects on appetite.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Obesity causes 600 premature deaths per week in the UK and existing treatments are less than ideal. Intravenous infusion of a hormone called PYY reduces food intake but its effects only last for a few hours and it can cause nausea. Y242 is a longacting analogue of PYY. Given subcutaneously in rodents, it has a profile of action of at least 72 hours and strongly inhibits food intake. It causes weight loss without behavioural effects. With MRC funding, Y242 has passed Good Laboratory Practice toxicology testing and the present proposal is a first in human study to investigate its safety, tolerability and pharmacokinetics in overweight but otherwise healthy men.

The study is a combined single ascending dose (part A) and multiple ascending dose (part B) Phase 1 investigation. The primary objective is to investigate safety and tolerability. The secondary objective is to assess Y242's pharmacokinetic (PK) profile. Possible effects on food consumption will be explored. For part A up to 48 subjects are planned, with up to 40 subjects for part B. In each part subjects are divided into groups, each of which is dosed with the same level, starting with a single dose (part A) much lower than is expected to cause an effect. Subjects are admitted to a Unit so they can be closely observed for adverse effects and safety tests, blood concentrations of the drug and food and liquid intake and output will be monitored. Subjects are allocated at random (like tossing a coin) to receive Y242 or placebo (dummy). Safety, tolerability and pharmacokinetic data will be summarised and available results considered in deciding dose escalation, with stopping rules designed to enable us to explore the relationship between dose and adverse effect (eg nausea) without causing unacceptable nausea or other symptoms in the volunteers.

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Part A was a single blind, randomised, placebo controlled, single ascending dose (SAD) study. Part B was a double blind, randomised, placebo controlled, multiple ascending dose (MAD) studyPart A was a single blind, randomised, placebo controlled, single ascending dose (SAD) study. Part B was a double blind, randomised, placebo controlled, multiple ascending dose (MAD) study
Masking:
Double (Participant, Investigator)
Masking Description:
Part A: Treatments were administered single-blind; subjects were blinded with regard to treatment and clinical staff remained blinded with regard to treatment until the Safety Committee meeting. Part B was double blind.
Primary Purpose:
Treatment
Official Title:
A Randomised, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y242 in Adult Subjects
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2mg Y242 (Part A)

Y242 single dose, subcutaneous

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Experimental: 7.5mg Y242 (Part A)

Y242 single dose, subcutaneous

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Experimental: 15mg Y242 (Part A)

Y242 single dose, subcutaneous

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Experimental: 30mg Y242 (Part A)

Y242 single dose, subcutaneous

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Experimental: 60mg Y242 (Part A)

Y242 single dose, subcutaneous

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Experimental: 90mg Y242 (Part A)

Y242 single dose, subcutaneous

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Placebo Comparator: Placebo - Part A

0.9% saline

Drug: 0.9% saline
Identical volume to that of Y242

Experimental: 60mg Y242 (Part B1)

Y242 single subcutaneous dose, administered once a week for 5 weeks

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Experimental: 90mg Y242 (Part B2-B4)

Y242 single subcutaneous dose, administered once a week for 5 weeks

Drug: Y242
Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)

Placebo Comparator: Placebo - Part B

0.9% saline

Drug: 0.9% saline
Identical volume to that of Y242

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) [Up to 73 days]

    A treatment-emergent AE (TEAE) as defined as an AE that started after administration of IMP; in Part B this was an AE that started after the first dose of IMP. Adverse events with onset prior to dosing were considered as pre-treatment AEs.

Secondary Outcome Measures

  1. Body Weight [up to 32 day]

    Summary of Time-Matched % Change from Baseline in Body Weight (Baseline = Day -1) following multiple dose of Y242 (Part B)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult males aged 18 to 50 years inclusive with BMI between 23.0 and 30.0 kg/m^2 inclusive;

  • Subjects who are healthy as determined by pre study medical history, physical examination and 12 lead ECG;

  • Subjects whose clinical laboratory test results are either within the normal range or if outside this range the abnormalities are judged to be not clinically relevant and are acceptable to the Investigator;

  • Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;

  • Subjects who are negative for drugs of abuse and alcohol tests at screening and admissions;

  • Subjects who are non-smokers for at least 3 months preceding screening;

  • Subjects who agree to use medically acceptable methods of contraception for at least 3 months after study drug administration;

  • Subjects who are able and willing to give written informed consent.

Exclusion Criteria:
  • Subjects who do not conform to the above inclusion criteria;

  • Subjects who have a clinically relevant history or presence of gastrointestinal (especially associated with vomiting), respiratory, renal, hepatic, haematological, lymphatic, neurological (especially if associated with balance disorders or vomiting e.g. migraine or labyrinthitis), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders;

  • Subjects who have a clinically relevant surgical history;

  • Subjects who have a clinically relevant family history;

  • Subjects who have a history of relevant atopy;

  • Subjects who have a history of relevant drug hypersensitivity;

  • Subjects who have a history of alcoholism;

  • Subjects who have a history of drug abuse;

  • Subjects who have a history of migraine;

  • Subjects who consume more than 21 units of alcohol a week (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer);

  • Subjects who have a significant infection or known inflammatory process on screening;

  • Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn);

  • Subjects who have an acute infection such as influenza at the time of screening or admission;

  • Subjects who have used prescription drugs within 4 weeks of first dosing;

  • Subjects who have used over the counter medication excluding routine vitamins and paracetamol but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as not clinically relevant by the Principal Investigator and Sponsor;

  • Subjects who have donated blood or blood products within 3 months of Day -2 (admission);

  • Subjects who have used any investigational drug in any clinical trial within 3 months of Day -2 (admission);

  • Subjects who have received the last dose of investigational drug greater than 3 months ago but who are on extended follow-up;

  • Subjects who have previously received Y242;

  • Subjects who are vegans or have any dietary restrictions;

  • Subjects who cannot communicate reliably with the Investigator;

  • Subjects who are unlikely to co-operate with the requirements of the study;

  • History or evidence of abnormal eating behaviour, as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires at screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PAREXEL Early Phase Clinical Unit London United Kingdom HA1 3UJ

Sponsors and Collaborators

  • Imperial College London
  • Medical Research Council

Investigators

  • Study Chair: Stephen Bloom DSc, MD FRCP, Imperial College London
  • Principal Investigator: John Lambert, MBBS PhD, Parexel
  • Study Director: Tricia Tan BSc MRCP, MB ChB, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01515319
Other Study ID Numbers:
  • QLON/2011/Y242-01
  • 2011-003549-17
First Posted:
Jan 24, 2012
Last Update Posted:
Feb 8, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title 2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B
Arm/Group Description Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) 0.9% saline 0.9% saline: Identical volume to that of Y242 Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) 0.9% saline - placebo
Period Title: Overall Study
STARTED 3 3 6 6 6 6 10 6 14 8
COMPLETED 3 3 6 6 6 6 9 6 9 8
NOT COMPLETED 0 0 0 0 0 0 1 0 5 0

Baseline Characteristics

Arm/Group Title 2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B Total
Arm/Group Description Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) 0.9% saline 0.9% saline: Identical volume to that of Y242 Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) 0.9% saline 0.9% saline: Identical volume to that of Y242 Total of all reporting groups
Overall Participants 3 3 6 6 6 6 10 6 14 8 68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
30.7
(2.52)
39.7
(5.51)
25.5
(5.79)
28.7
(9.2)
31.5
(11.47)
34.3
(7.5)
31.3
(6.04)
35.7
(6.62)
29.4
(7.1)
34.6
(6.76)
31.6
(7.61)
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Male
3
100%
3
100%
6
100%
6
100%
6
100%
6
100%
10
100%
6
100%
14
100%
8
100%
68
100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
1
16.7%
0
0%
0
0%
0
0%
1
10%
0
0%
1
7.1%
0
0%
3
4.4%
Black or African American
1
33.3%
0
0%
1
16.7%
1
16.7%
0
0%
1
16.7%
1
10%
0
0%
1
7.1%
1
12.5%
7
10.3%
White
2
66.7%
3
100%
4
66.7%
3
50%
6
100%
5
83.3%
6
60%
6
100%
9
64.3%
7
87.5%
51
75%
More than one race
0
0%
0
0%
0
0%
2
33.3%
0
0%
0
0%
2
20%
0
0%
3
21.4%
0
0%
7
10.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic Or Latino
0
0%
0
0%
0
0%
1
16.7%
0
0%
0
0%
2
20%
1
16.7%
0
0%
0
0%
4
5.9%
Not Hispanic Or Latino
3
100%
3
100%
6
100%
5
83.3%
6
100%
6
100%
8
80%
5
83.3%
14
100%
8
100%
64
94.1%
Region of Enrollment (participants) [Number]
United Kingdom
3
100%
3
100%
6
100%
6
100%
6
100%
6
100%
10
100%
6
100%
14
100%
8
100%
68
100%
Height (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]
183.3
(8.39)
174.3
(5.69)
177.2
(5.71)
180.8
(9.99)
177.7
(4.97)
179.0
(4.29)
176.5
(6.82)
174.3
(7.09)
179.9
(6.32)
180.9
(6.58)
178.3
(6.55)
Weight (kg) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]
87.5
(2.893)
80.27
(7.199)
84.58
(7.618)
83.63
(10.723)
82.52
(11.618)
83.28
(9.781)
81.10
(10.363)
76.18
(7.537)
84.37
(7.846)
89.89
(7.906)
83.5
(9.01)
BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
26.13
(1.845)
26.37
(0.929)
26.88
(1.148)
25.55
(2.128)
26.05
(2.595)
25.93
(2.325)
25.94
(1.731)
25.03
(1.462)
26.07
(1.920)
27.46
(1.431)
26.2
(1.84)

Outcome Measures

1. Primary Outcome
Title Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
Description A treatment-emergent AE (TEAE) as defined as an AE that started after administration of IMP; in Part B this was an AE that started after the first dose of IMP. Adverse events with onset prior to dosing were considered as pre-treatment AEs.
Time Frame Up to 73 days

Outcome Measure Data

Analysis Population Description
Summary statistics included number of subjects, arithmetic mean and standard deviation.
Arm/Group Title 2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B
Arm/Group Description Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) 0.9% saline 0.9% saline: Identical volume to that of Y242 Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) 0.9% saline 0.9% saline: Identical volume to that of Y242
Measure Participants 3 3 6 6 6 6 10 6 14 8
Total number of AEs
0
0%
3
100%
6
100%
6
100%
6
100%
6
100%
6
60%
6
100%
14
100%
7
87.5%
Serious TEAEs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
TEAEs leading to discontinuation
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
3
21.4%
0
0%
TEAEs leading to death
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2. Secondary Outcome
Title Body Weight
Description Summary of Time-Matched % Change from Baseline in Body Weight (Baseline = Day -1) following multiple dose of Y242 (Part B)
Time Frame up to 32 day

Outcome Measure Data

Analysis Population Description
Part B - Body weight change from baseline (%) following 5 weekly doses of Y242
Arm/Group Title 2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B
Arm/Group Description Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) 0.9% saline 0.9% saline: Identical volume to that of Y242 Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) 0.9% saline 0.9% saline: Identical volume to that of Y242
Measure Participants 0 0 0 0 0 0 0 6 9 8
Mean (Standard Deviation) [Percentage change in Body weight]
-1.2
(1.9)
-1.0
(1.8)
1.8
(3.4)

Adverse Events

Time Frame 73 days until final follow up visit
Adverse Event Reporting Description The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Arm/Group Title 2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B
Arm/Group Description Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) Y242 single dose, subcutaneous (Part A) 0.9% saline 0.9% saline: Identical volume to that of Y242 Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B) 0.9% saline 0.9% saline: Identical volume to that of Y242
All Cause Mortality
2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/10 (0%) 0/6 (0%) 0/14 (0%) 0/8 (0%)
Serious Adverse Events
2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/10 (0%) 0/6 (0%) 0/14 (0%) 0/8 (0%)
Other (Not Including Serious) Adverse Events
2mg Y242 7.5mg Y242 15mg Y242 30mg Y242 60mg Y242 90mg Y242 Placebo - Part A 60mg Y242 (B1) 90mg Y242 (B2-B4) Placebo - Part B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3 (0%) 3/3 (100%) 6/6 (100%) 6/6 (100%) 6/6 (100%) 6/6 (100%) 6/10 (60%) 6/6 (100%) 14/14 (100%) 7/8 (87.5%)
Cardiac disorders
Palpitations 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/8 (0%) 0
Gastrointestinal disorders
Abdominal Discomfort 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Abdominal Distension 0/3 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Abdominal Pain 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Abdominal Pain Upper 0/3 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/8 (0%) 0
Diarrhoea 0/3 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 1/6 (16.7%) 1 0/10 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/8 (0%) 0
Dyspepsia 0/3 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Nausea 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 3 5/6 (83.3%) 5 4/6 (66.7%) 4 0/10 (0%) 0 4/6 (66.7%) 12 14/14 (100%) 39 1/8 (12.5%) 1
Tooth Ache 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Vomiting 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 2/6 (33.3%) 2 1/6 (16.7%) 1 0/10 (0%) 0 0/6 (0%) 0 4/14 (28.6%) 4 0/8 (0%) 0
Constipation 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/8 (0%) 0
General disorders
Feeling hot 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Induration 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Influenza-like Illness 0/3 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Injection site Discolouration 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Injection Site Induration 0/3 (0%) 0 0/3 (0%) 0 2/6 (33.3%) 2 1/6 (16.7%) 1 1/6 (16.7%) 1 1/6 (16.7%) 1 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Injection Site Pain 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Injection Site Pruritus 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Injection Site Reaction 0/3 (0%) 0 3/3 (100%) 4 5/6 (83.3%) 7 5/6 (83.3%) 7 6/6 (100%) 6 6/6 (100%) 7 1/10 (10%) 1 6/6 (100%) 29 14/14 (100%) 58 1/8 (12.5%) 1
Catheter Site Pain 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/8 (0%) 0
Chest discomfort 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/8 (0%) 0
Fatigue 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 2/14 (14.3%) 2 0/8 (0%) 0
Feeling of Body temperature change 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/8 (0%) 0
Infections and infestations
Gastoenteritis 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/8 (0%) 0
Influenza 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/8 (0%) 0
Nasopharyngitis 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 1/6 (16.7%) 1 2/10 (20%) 2 1/6 (16.7%) 1 2/14 (14.3%) 2 2/8 (25%) 2
Pharyngitis 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Oral Herpes 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/8 (12.5%) 1
Rhinitis 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 1/8 (12.5%) 1
Injury, poisoning and procedural complications
Contusion 0/3 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 1/8 (12.5%) 1
Laceration 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 1/8 (12.5%) 1
Muscle injury 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/10 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/8 (0%) 0
Metabolism and nutrition disorders
Decreased appetite 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 1/10 (10%) 1 2/6 (33.3%) 2 1/14 (7.1%) 1 0/8 (0%) 0
Musculoskeletal and connective tissue disorders
Back pain 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 2/14 (14.3%) 2 0/8 (0%) 0
Nervous system disorders
Dizziness 0/3 (0%) 0 0/3 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 2/6 (33.3%) 2 1/10 (10%) 1 0/6 (0%) 0 2/14 (14.3%) 2 1/8 (12.5%) 1
Dysgeusia 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 1/14 (7.1%) 1 0/8 (0%) 0
Headache 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 4/6 (66.7%) 6 5/14 (35.7%) 10 3/8 (37.5%) 4
Paraesthesia 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Pharyngeal Hypoaestesia 0/3 (0%) 0 1/3 (33.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Rhinorrhoea 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Sinus Congestion 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Throat Irritation 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Epistaxis 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/8 (0%) 0
Skin and subcutaneous tissue disorders
Skin Irritation 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/10 (10%) 1 0/6 (0%) 0 0/14 (0%) 0 0/8 (0%) 0
Eczema 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 1/6 (16.7%) 1 0/14 (0%) 0 0/8 (0%) 0
Petechiae 0/3 (0%) 0 0/3 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/10 (0%) 0 0/6 (0%) 0 1/14 (7.1%) 1 0/8 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr Tricia Tan
Organization Imperial College London
Phone 020 838 38038
Email t.tan@imperial.ac.uk
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01515319
Other Study ID Numbers:
  • QLON/2011/Y242-01
  • 2011-003549-17
First Posted:
Jan 24, 2012
Last Update Posted:
Feb 8, 2021
Last Verified:
Jan 1, 2021