Trial Outcomes & Findings for Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers (NCT NCT03171415)
NCT ID: NCT03171415
Last Updated: 2019-08-21
Results Overview
AEs will be assessed by significant clinical changes in safety parameter (e.g. vital signs, ECG, clinical laboratory evaluations)AEs incidence will be by body system, seriousness, severity and relation to study drug by cohort.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
0-168 days
Results posted on
2019-08-21
Participant Flow
Study was designed to enroll 32 subjects. In practice, 33 subjects were enrolled into the study. In cohort 3, one subject that was injected with plcebo was lost to follow up 3 days following injection. Therefore, an additional subject was enrolled and injected with placebo but he also was lost to follow up, 7 days following injection.
Participant milestones
| Measure |
RZL-012 Cohort 1
A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
A single-time injection, multiple subcutaneous injections of 80 mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
A single-time injection, multiple subcutaneous injections of 120 mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
A single-time injection, multiple subcutaneous injections of 180 mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36 (0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of Placebo are administered at 8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
9
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
RZL-012 Cohort 1
A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
A single-time injection, multiple subcutaneous injections of 80 mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
A single-time injection, multiple subcutaneous injections of 120 mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
A single-time injection, multiple subcutaneous injections of 180 mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36 (0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of Placebo are administered at 8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers
Baseline characteristics by cohort
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16(0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24(0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36(0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=9 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
40 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
39.2 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
39.4 years
STANDARD_DEVIATION 10.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
9 participants
n=21 Participants
|
33 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 0-168 daysPopulation: 20-60 years old, overweight and obese by BMI definition (27.5 \< BMI ≤ 34.9), adult males.
AEs will be assessed by significant clinical changes in safety parameter (e.g. vital signs, ECG, clinical laboratory evaluations)AEs incidence will be by body system, seriousness, severity and relation to study drug by cohort.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=9 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Other Adverse Events
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
9 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Ear and labyrinth disorders Ear swelling
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Aministration site condition - Fatifue
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - feeling hot
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - nodule
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition- Edema
|
6 participants
|
4 participants
|
6 participants
|
4 participants
|
5 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - pain
|
6 participants
|
5 participants
|
5 participants
|
5 participants
|
3 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition medical device reac
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
general condition non cardiac chest pain
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Investigations - Electrodiagram QT prolonged
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Muscoloskeletal and connective tissue - pain extre
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Nervou system disorders- Dizziness
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Respeiratory, thoracic - oropharyngea pain
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Respeiratory, thoracic - Respiratory tracongestion
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Respeiratory, thoracic - Rhinorrhoea
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
skin and subcutaneous tissue disorders - erythema
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Cardiac disorder ventricular extrasystoles
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Ear and labyrinth disorders - Ear pain
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Ear and labyrinth disorders - Hypoacusis
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Ear and labyrinth disorders otorrhoea
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Aministration site condition - energy uncreased
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - bruising
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - discolourization
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - Erythema
|
6 participants
|
6 participants
|
4 participants
|
5 participants
|
8 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - hemorrhage
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - injection mass
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition- pruritus
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - rash
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Administration site condition - warmth
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Injury and procedure complications - skin abrasion
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Muscoloskeletal and connective tissue - myalgia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
Nervou system disorders - Headache
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
skin and subcutaneous tissue disorders hyperhidros
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Safety: The Incidence of Treatment-related Adverse Events [AEs]
skin and subcutaneous tissue disorders - pruritus
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 28-168 daysThermogenesis is measured by thermal imaging is non-invasive, non-radiating Infra-Red thermal camera that passively measures the emitting infra-red radiation of body surface. Difference in temperatures between the sites (treated - not treated) by visit treatment along with the change from baseline (net-delta) in these differences by cohort and overall. Significant thermogenesis is defined as net-delta ≥ 1. Outcome measure data table represents the number of subjects who demonstrated an increase that is higher than 1 celsius degree.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=7 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Efficacy: A Significant Thermogenesis at the Injected Site.
Day 28
|
5 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Efficacy: A Significant Thermogenesis at the Injected Site.
Day 56
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Efficacy: A Significant Thermogenesis at the Injected Site.
Day 84
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
4 Participants
|
0 Participants
|
|
Efficacy: A Significant Thermogenesis at the Injected Site.
Day 112
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
5 Participants
|
0 Participants
|
|
Efficacy: A Significant Thermogenesis at the Injected Site.
Day 168
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
3 Participants
|
0 Participants
|
|
Efficacy: A Significant Thermogenesis at the Injected Site.
Day 140
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
NA Participants
measure was not taken at this time point
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28-168 daysThe duration of the thermogenic effect for subjects in the active arm with thermogenic effect (net-delta ≥ 1) by visit and cohort.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=7 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Duration of the Thermogenic Effect From Day 28.
|
5.6 days
Standard Deviation 12.5
|
16.8 days
Standard Deviation 15.3
|
5.6 days
Standard Deviation 12.5
|
107.3 days
Standard Deviation 44.9
|
0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 28-168 daysPopulation: In cohort 4, one subjects was not analyzed due to MRI image quality (bubble)
Subcutaneous Fat Mass (SFM) ratio (treated sites / control sites) averaged over the MRI slices by visit, treatment and cohort and the change from baseline in SFM ratio (in % from the ratio at baseline) compared between the treatment arms.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=5 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=7 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.
Day 56
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 1 subjects
|
-8.56 percentage of SFM reduction
Standard Deviation 8.85
|
-10.52 percentage of SFM reduction
Standard Deviation 8.42
|
-18.10 percentage of SFM reduction
Standard Deviation 10.93
|
3.61 percentage of SFM reduction
Standard Deviation 3.48
|
|
Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.
Day 84
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 1 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 2 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 3 subjects
|
-12.75 percentage of SFM reduction
Standard Deviation 9.83
|
-6.57 percentage of SFM reduction
Standard Deviation 9.78
|
|
Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.
Day 112
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 1 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 2 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 3 subjects
|
-16.10 percentage of SFM reduction
Standard Deviation 13.81
|
-8.2 percentage of SFM reduction
Standard Deviation 11.54
|
|
Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.
Day 140
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 1 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 2 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 3 subjects
|
-12.46 percentage of SFM reduction
Standard Deviation 11.26
|
-2.9 percentage of SFM reduction
Standard Deviation 0.45
|
|
Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.
Day 28
|
-0.62 percentage of SFM reduction
Standard Deviation 5.17
|
-9.15 percentage of SFM reduction
Standard Deviation 10.55
|
-9.1 percentage of SFM reduction
Standard Deviation 4.27
|
-14.68 percentage of SFM reduction
Standard Deviation 8.16
|
2.94 percentage of SFM reduction
Standard Deviation 10.08
|
|
Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.
Day 168
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 1 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 2 subjects
|
NA percentage of SFM reduction
Standard Deviation NA
Measurement was not perform at this time point for cohort 3 subjects
|
-14.32 percentage of SFM reduction
Standard Deviation 10.94
|
-2.54 percentage of SFM reduction
Standard Deviation 8.57
|
SECONDARY outcome
Timeframe: 56 daysChanges from baseline in fasting blood glucose by visit, treatment, and cohort.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=7 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Changes in Fasting Blood Glucose From Baseline.
Day -1
|
86.7 mg/dL
Standard Deviation 4.2
|
91.3 mg/dL
Standard Deviation 5.16
|
91.7 mg/dL
Standard Deviation 7.47
|
90.8 mg/dL
Standard Deviation 7.17
|
93.2 mg/dL
Standard Deviation 3.93
|
|
Changes in Fasting Blood Glucose From Baseline.
Day 56
|
93 mg/dL
Standard Deviation 3.22
|
92.8 mg/dL
Standard Deviation 11.8
|
93.3 mg/dL
Standard Deviation 7.58
|
93.7 mg/dL
Standard Deviation 5.3
|
94.6 mg/dL
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 56 daysChanges from baseline in lipid profile by visit, treatment, and cohort.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=7 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Changes in Blood Lipid Profile From Baseline.
Cholesterol Day -1
|
188 mg/dL
Standard Deviation 32.8
|
199 mg/dL
Standard Deviation 11
|
196 mg/dL
Standard Deviation 41.4
|
170.8 mg/dL
Standard Deviation 23
|
186.7 mg/dL
Standard Deviation 19.8
|
|
Changes in Blood Lipid Profile From Baseline.
Cholesterol Day 56
|
184 mg/dL
Standard Deviation 39.8
|
205 mg/dL
Standard Deviation 29.7
|
201.7 mg/dL
Standard Deviation 46.1
|
176 mg/dL
Standard Deviation 28.6
|
182.4 mg/dL
Standard Deviation 19.3
|
|
Changes in Blood Lipid Profile From Baseline.
HDL Day -1
|
43.5 mg/dL
Standard Deviation 7.23
|
44.33 mg/dL
Standard Deviation 11.1
|
41.5 mg/dL
Standard Deviation 6
|
44 mg/dL
Standard Deviation 6.87
|
42.44 mg/dL
Standard Deviation 5.6
|
|
Changes in Blood Lipid Profile From Baseline.
HDL Day 56
|
40 mg/dL
Standard Deviation 9.44
|
50.8 mg/dL
Standard Deviation 14.2
|
41.5 mg/dL
Standard Deviation 9.9
|
45.3 mg/dL
Standard Deviation 5.05
|
41.14 mg/dL
Standard Deviation 7
|
|
Changes in Blood Lipid Profile From Baseline.
LDL Day -1
|
129 mg/dL
Standard Deviation 33.5
|
126.5 mg/dL
Standard Deviation 13.3
|
134 mg/dL
Standard Deviation 33
|
105.5 mg/dL
Standard Deviation 15
|
116 mg/dL
Standard Deviation 10.3
|
|
Changes in Blood Lipid Profile From Baseline.
LDL Day 56
|
120 mg/dL
Standard Deviation 31.3
|
132 mg/dL
Standard Deviation 23.9
|
134.7 mg/dL
Standard Deviation 37
|
128 mg/dL
Standard Deviation 0
|
103 mg/dL
Standard Deviation 14.8
|
|
Changes in Blood Lipid Profile From Baseline.
Triglycerides Day -1
|
107.3 mg/dL
Standard Deviation 42.3
|
131 mg/dL
Standard Deviation 77
|
112.5 mg/dL
Standard Deviation 58.9
|
121.7 mg/dL
Standard Deviation 39.3
|
155.8 mg/dL
Standard Deviation 98
|
|
Changes in Blood Lipid Profile From Baseline.
Triglycerides Day 56
|
118 mg/dL
Standard Deviation 85.4
|
136 mg/dL
Standard Deviation 61.1
|
193.5 mg/dL
Standard Deviation 16.7
|
128.33 mg/dL
Standard Deviation 55.4
|
234 mg/dL
Standard Deviation 220
|
SECONDARY outcome
Timeframe: 1-2 daysAveraged Cmax values by cohort.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.
|
84.15 ng/mL
Standard Deviation 16.27
|
181.89 ng/mL
Standard Deviation 49.86
|
241 ng/mL
Standard Deviation 72.09
|
344 ng/mL
Standard Deviation 73.7
|
—
|
SECONDARY outcome
Timeframe: 56 daysChanges from baseline in body weight by visit, treatment, and cohort.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=7 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Changes in Body Weight
Weight Day -1
|
103.3 Kg
Standard Deviation 11.1
|
95.4 Kg
Standard Deviation 6.9
|
101.3 Kg
Standard Deviation 20.3
|
96.1 Kg
Standard Deviation 12.6
|
99.1 Kg
Standard Deviation 8.1
|
|
Changes in Body Weight
Weight Day 56
|
104.4 Kg
Standard Deviation 12.5
|
96.1 Kg
Standard Deviation 7.8
|
103.4 Kg
Standard Deviation 22.4
|
96 Kg
Standard Deviation 12.3
|
101.2 Kg
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 56 daysChanges from baseline in WHR by visit, treatment, and cohort. WHR is calculated by measurements of waist circumference and hip circumference.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=7 Participants
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Changes in Waist to Hip Ratio [WHR]
Waist to hip ratio Day 56
|
1 ratio
Standard Error 0
|
1 ratio
Standard Error 0
|
1 ratio
Standard Error 0
|
1 ratio
Standard Error 0
|
1 ratio
Standard Error 0.1
|
|
Changes in Waist to Hip Ratio [WHR]
Waist to hip ratio Day -1
|
1 ratio
Standard Error 0.1
|
1 ratio
Standard Error 0
|
1 ratio
Standard Error 0.1
|
1 ratio
Standard Error 0
|
1 ratio
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 56 daysPopulation: Biopsy was done only for 2 active and 1 placebo subjects in cohort 3. Biopsy was not done in subjects from cohorts 1,2 or 4.
An abdominal subcutaneous adipose tissue biopsy will be taken from the injected side. Histology results will be assessed for 2 subjects who were injected with 120 mg RZL-012 and for one subject who was injected with placebo.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=2 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=1 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Elucidation of the Histological Changes Account for the Thermogenic Effect.
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 daysPopulation: The study was designed in a way that inflammation marker will be measured only for active and placebo subjects from cohorts 2-4
Changes from baseline in inflammatory markers and cytokines by visit, treatment, and cohort. Testing of inflammatory markers and cytokines will be conducted by blood sampling.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=5 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Change From Baseline in Inflammatory Markers and Cytokines. Testing of Inflammatory Markers and Cytokines Will be Conducted by Blood Sampling.
CRP Day -1 (mg/dL)
|
0.2 mg/dL
Standard Deviation 0.13
|
0.6 mg/dL
Standard Deviation 1.08
|
0.5 mg/dL
Standard Deviation 0
|
0.2 mg/dL
Standard Deviation 0.1
|
—
|
|
Change From Baseline in Inflammatory Markers and Cytokines. Testing of Inflammatory Markers and Cytokines Will be Conducted by Blood Sampling.
CRP Day 28 (mg/dL)
|
0.27 mg/dL
Standard Deviation 0.31
|
0.2 mg/dL
Standard Deviation 0.12
|
0.43 mg/dL
Standard Deviation 0.15
|
0.2 mg/dL
Standard Deviation 0.1
|
—
|
SECONDARY outcome
Timeframe: 0.5, 1,2,3,4,5,6,8,12,16,24,30 hoursAveraged Tmax values by cohort.
Outcome measures
| Measure |
RZL-012 Cohort 1
n=6 Participants
A single-time injection, multiple subcutaneous injections of 40 RZL-012 administered into 8 sites (0.1mL per site):
RZL-012: Subject receive a single-time injection. Multiple injections of RZL-012 are administered at doses of 40-180mg (8-36 injection sites, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 Participants
A single-time injection, multiple subcutaneous injections of 80mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 Participants
A single-time injection, multiple subcutaneous injections of 120mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180mg doses (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 Participants
A single-time injection, multiple subcutaneous injections of 180mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 40-180 mg (8-36 injections, 0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site)
Placebo: Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8/16/24/36 sites (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.
|
1.83 Hour
Standard Deviation 0.41
|
1.83 Hour
Standard Deviation 0.41
|
1.83 Hour
Standard Deviation 0.41
|
2 Hour
Standard Deviation 0
|
—
|
Adverse Events
RZL-012 Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
RZL-012 Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
RZL-012 Cohort 3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
RZL-012 Cohort 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RZL-012 Cohort 1
n=6 participants at risk
A single-time injection, multiple subcutaneous injections of 40mg RZL-012 administered into 8 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 2
n=6 participants at risk
A single-time injection, multiple subcutaneous injections of 80 mg RZL-012 administered into 16 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 16 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 3
n=6 participants at risk
A single-time injection, multiple subcutaneous injections of 120 mg RZL-012 administered into 24 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 24 (0.1mL per site) into the abdominal subcutaneous fat.
|
RZL-012 Cohort 4
n=6 participants at risk
A single-time injection, multiple subcutaneous injections of 180 mg RZL-012 administered into 36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 36 (0.1mL per site) into the abdominal subcutaneous fat.
|
Placebo
n=9 participants at risk
A single-time injection, multiple subcutaneous injections of Placebo administered into 8/16/24/36 sites (0.1mL per site):
Subject receive a single-time injection. Multiple injections of Placebo are administered at 8/16/24/36 (0.1mL per site) into the abdominal subcutaneous fat.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Ear and labyrinth disorders
ear pain
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Ear and labyrinth disorders
ear swelling
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Energy increased
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
fatigue
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Feeling hot
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
33.3%
2/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
33.3%
3/9 • Number of events 3 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site discolouration
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site Erythema
|
100.0%
6/6 • Number of events 6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
100.0%
6/6 • Number of events 7 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
66.7%
4/6 • Number of events 5 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
83.3%
5/6 • Number of events 7 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
88.9%
8/9 • Number of events 11 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site hemmorhage
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site mass
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site nodule
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site Edema
|
100.0%
6/6 • Number of events 7 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
66.7%
4/6 • Number of events 4 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
100.0%
6/6 • Number of events 7 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
66.7%
4/6 • Number of events 5 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
55.6%
5/9 • Number of events 6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site pain
|
100.0%
6/6 • Number of events 6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
83.3%
5/6 • Number of events 5 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
83.3%
5/6 • Number of events 8 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
83.3%
5/6 • Number of events 6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
33.3%
3/9 • Number of events 3 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site pruritus
|
33.3%
2/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
33.3%
2/6 • Number of events 3 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site rash
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Injection site warmth
|
33.3%
2/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Medical device reaction
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
General disorders
Non cardiac chest pain
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Investigations
Electrocardiac QT prolonged
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
33.3%
2/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
11.1%
1/9 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Respiratory, thoracic and mediastinal disorders
Orpharyngeal pain
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 2 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
50.0%
3/6 • Number of events 3 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/6 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
16.7%
1/6 • Number of events 1 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
0.00%
0/9 • All reported adverse events were coded to a standard set of terms using MedDRA coding dictionary. Cohort 4 subjects were followed up for Adverse Events up to 168 days following injection.
None of the subjects was reported with SAEs. None of the subjects died during the study
|
Additional Information
Racheli Gueta - Clinical Trials Manager
Raziel Therapeutics
Phone: 972-8-9126941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place