Heart Failure
Conditions
Brief summary
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
Detailed description
Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure.
Interventions
DRUGGlial growth factor 2/ Neuregulin 1β3
OTHERPlacebo
Sponsors
Acorda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Left ventricular ejection fraction (LVEF) between 10% and 40%. 2. Male or female, aged 18 to 75 years, inclusive.
Exclusion criteria
1. Received any investigational agent or participation in any clinical study of an investigational agent or investigational therapy up to 30 days prior to the screening visit. 2. Use of any new prescription medication up to 14 days prior to receiving investigational drug. 3. Patients with known specific hepatic disease; bilirubin \>2 mg/dL, SGOT \> 100 IU. 4. Patients with a history of hepatic impairment (hepatitis B and C). 5. Serum creatinine \>2.5 mg/dL. 6. Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | 6 months | Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Screening, day 8, day 14, day 28, and 3 months post-dose | An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹ Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.² ¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/ ²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286 |
| Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Screening, day 8, day 14, day 28, and 3 months post-dose | EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume |
| Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Screening, day 8, day 14, day 28, and 3 months post-dose | ESV is the volume of blood remaining in each ventricle at the end of systole.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume |
Countries
United States
Participant flow
Recruitment details
After informed consent, 40 patients with symptomatic Heart Failure (HF) were randomized (4:2) to GGF2 or placebo in 7 ascending dose cohorts. Patients were observed in hospital for 30 hours, then evaluated for adverse effects at 1, 2, 4, 12, and 24 weeks after infusion.
Pre-assignment details
There were six patients in each cohort/dose level, four received active treatment (GGF2) and two received placebo. In each dose level, the first two patients were randomized 1:1 to GGF2 or placebo and monitored for safety prior to randomizing the remaining patients in the cohort 3:1. GGF2 or placebo was administered as an IV infusion.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients in each of 7 cohorts randomized to Placebo | 13 |
| GGF2 First Dose First dosing: patients in cohort randomized to GGF2 | 4 |
| GGF2 Second Escalated Dose Second dosing: patients in cohort randomized to GGF2 | 4 |
| GGF2 Third Escalated Dose Third dosing: patients in cohort randomized to GGF2 | 4 |
| GGF2 Fourth Escalated Dose Fourth dosing: patients in cohort randomized to GGF2 | 4 |
| GGF2 Fifth Escalated Dose Fifth dosing: patients in cohort randomized to GGF2 | 4 |
| GGF2 Sixth Escalated Dose Sixth dosing: patients in cohort randomized to GGF2. | 4 |
| GGF2 Seventh Escalataed Dose Seventh dosing: patients in cohort randomized to GGF2 | 3 |
| Total | 40 |
Baseline characteristics
| Characteristic | Placebo | GGF2 First Dose | GGF2 Second Escalated Dose | GGF2 Third Escalated Dose | GGF2 Fourth Escalated Dose | GGF2 Fifth Escalated Dose | GGF2 Sixth Escalated Dose | GGF2 Seventh Escalataed Dose | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 13.21 | 52.0 years STANDARD_DEVIATION 5.72 | 58.5 years STANDARD_DEVIATION 7.59 | 56.8 years STANDARD_DEVIATION 10.05 | 65.3 years STANDARD_DEVIATION 5.85 | 58.5 years STANDARD_DEVIATION 8.85 | 59.0 years STANDARD_DEVIATION 4.97 | 61.0 years STANDARD_DEVIATION 9.17 | 57.4 years STANDARD_DEVIATION 9.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 7 Participants |
| Sex: Female, Male Male | 12 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 13 | 4 / 4 | 4 / 4 | 2 / 4 | 4 / 4 | 4 / 4 | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 0 / 13 | 1 / 4 | 1 / 4 | 0 / 4 | 1 / 4 | 0 / 4 | 0 / 4 | 1 / 3 |
Outcome results
Primary
Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)
Safety/ tolerability of single dose; cumulative safety over 6 months TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment.
Time frame: 6 months
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 6 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 5 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 1 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 5 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 0 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 1 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 1 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 13 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 7 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 5 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 0 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| Placebo | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 3 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 1 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 3 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 0 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 1 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 3 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 0 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 4 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 4 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 0 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| GGF2 First Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 1 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 1 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 3 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 0 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 0 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 4 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 3 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 1 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 0 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 3 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 1 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 Second Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 4 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 2 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 2 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 0 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 0 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 2 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 4 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 0 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 1 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 0 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 2 participants |
| GGF2 Third Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 1 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 1 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 3 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 4 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 4 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 0 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 1 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 2 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 1 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 1 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 2 participants |
| GGF2 Fourth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 1 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 1 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 1 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 2 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 0 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 1 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 3 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 2 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 1 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 4 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 1 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| GGF2 Fifth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 4 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 0 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 3 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 2 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 1 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 2 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 0 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 2 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 0 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 2 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 4 participants |
| GGF2 Sixth Escalated Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 4 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Not Related | 0 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Severe | 1 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Mild | 0 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - No | 0 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Moderate | 2 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Moderate | 1 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Relationship to Study Drug -Related | 3 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having Any TEAEs - Yes | 3 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | TEAEs Maximum Toxicity Grade Life-Threatening | 0 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Severity Severe | 1 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Death | 0 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - Yes | 0 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Having TEAEs Maximum Toxicity Grade Mild | 1 participants |
| GGF2 Seventh Escalataed Dose | Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs) | Withdrew Due to TEAEs - NO | 3 participants |
Secondary
Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)
EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
Time frame: Screening, day 8, day 14, day 28, and 3 months post-dose
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | -14.89 Milliliter(s) | Standard Deviation 74.125 |
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | -41.59 Milliliter(s) | Standard Deviation 55.252 |
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | -25.85 Milliliter(s) | Standard Deviation 63.405 |
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | -25.72 Milliliter(s) | Standard Deviation 109.056 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | 2.85 Milliliter(s) | Standard Deviation 43.507 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | 31.95 Milliliter(s) | Standard Deviation 9.45 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | 27.50 Milliliter(s) | Standard Deviation 27.538 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | 13.60 Milliliter(s) | Standard Deviation 21.75 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | 1.98 Milliliter(s) | Standard Deviation 29.028 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | -8.00 Milliliter(s) | Standard Deviation 46.168 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | -10.25 Milliliter(s) | Standard Deviation 56.119 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | 49.18 Milliliter(s) | Standard Deviation 52.333 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | -10.60 Milliliter(s) | Standard Deviation 59.288 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | -32.83 Milliliter(s) | Standard Deviation 44.543 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | -21.05 Milliliter(s) | Standard Deviation 41.282 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | 48.78 Milliliter(s) | Standard Deviation 66.896 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | -20.00 Milliliter(s) | Standard Deviation 36.615 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | 10.50 Milliliter(s) | Standard Deviation 54.482 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | -22.25 Milliliter(s) | Standard Deviation 30.609 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | -2.15 Milliliter(s) | Standard Deviation 11.098 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | -39.85 Milliliter(s) | Standard Deviation 52.616 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | -15.80 Milliliter(s) | Standard Deviation 20.785 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | -26.50 Milliliter(s) | Standard Deviation 33.071 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | -35.00 Milliliter(s) | Standard Deviation 36.341 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | -12.98 Milliliter(s) | Standard Deviation 116.297 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | 17.00 Milliliter(s) | Standard Deviation 23.763 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | -15.25 Milliliter(s) | Standard Deviation 74.384 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | -23.50 Milliliter(s) | Standard Deviation 61.474 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 14 | 17.85 Milliliter(s) | Standard Deviation 19.587 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 28 | -3.30 Milliliter(s) | Standard Deviation 13.262 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | 3 Months | 4.07 Milliliter(s) | Standard Deviation 30.624 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV) | Day 8 | 7.33 Milliliter(s) | Standard Deviation 5.859 |
Secondary
Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)
ESV is the volume of blood remaining in each ventricle at the end of systole.¹ ¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume
Time frame: Screening, day 8, day 14, day 28, and 3 months post-dose
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | -3.48 Milliliter(s) | Standard Deviation 92.552 |
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | -19.08 Milliliter(s) | Standard Deviation 76.181 |
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | -12.65 Milliliter(s) | Standard Deviation 128.433 |
| Placebo | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | -0.92 Milliliter(s) | Standard Deviation 79.285 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | 10.88 Milliliter(s) | Standard Deviation 22.885 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | 12.38 Milliliter(s) | Standard Deviation 31.669 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | 6.30 Milliliter(s) | Standard Deviation 32.395 |
| GGF2 First Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | 33.20 Milliliter(s) | Standard Deviation 14.2 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | 22.05 Milliliter(s) | Standard Deviation 41.977 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | -14.40 Milliliter(s) | Standard Deviation 30.961 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | -0.45 Milliliter(s) | Standard Deviation 32.211 |
| GGF2 Second Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | -6.98 Milliliter(s) | Standard Deviation 29.443 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | -23.45 Milliliter(s) | Standard Deviation 30.33 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | 27.80 Milliliter(s) | Standard Deviation 43.414 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | -27.65 Milliliter(s) | Standard Deviation 31.115 |
| GGF2 Third Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | -15.95 Milliliter(s) | Standard Deviation 44.215 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | -21.25 Milliliter(s) | Standard Deviation 23.782 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | -8.88 Milliliter(s) | Standard Deviation 25.873 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | -5.25 Milliliter(s) | Standard Deviation 15.392 |
| GGF2 Fourth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | -15.00 Milliliter(s) | Standard Deviation 20.314 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | -27.25 Milliliter(s) | Standard Deviation 39.339 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | -26.50 Milliliter(s) | Standard Deviation 30.49 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | -24.75 Milliliter(s) | Standard Deviation 26.725 |
| GGF2 Fifth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | -39.08 Milliliter(s) | Standard Deviation 48.393 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | -31.75 Milliliter(s) | Standard Deviation 58.75 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | -28.75 Milliliter(s) | Standard Deviation 60.808 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | -9.00 Milliliter(s) | Standard Deviation 29.017 |
| GGF2 Sixth Escalated Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | -18.58 Milliliter(s) | Standard Deviation 87.663 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 14 | 4.10 Milliliter(s) | Standard Deviation 2.97 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | 3 Months | -10.73 Milliliter(s) | Standard Deviation 36.96 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 28 | -16.30 Milliliter(s) | Standard Deviation 8.311 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV) | Day 8 | -3.23 Milliliter(s) | Standard Deviation 12.894 |
Secondary
Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)
An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹ Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.² ¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/ ²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286
Time frame: Screening, day 8, day 14, day 28, and 3 months post-dose
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | -1.12 percent change | Standard Deviation 7.88 |
| Placebo | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | -0.82 percent change | Standard Deviation 6.582 |
| Placebo | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | 1.88 percent change | Standard Deviation 8.588 |
| Placebo | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | -0.27 percent change | Standard Deviation 8.584 |
| GGF2 First Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | -2.00 percent change | Standard Deviation 9.345 |
| GGF2 First Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | -5.00 percent change | Standard Deviation 7.257 |
| GGF2 First Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | -3.75 percent change | Standard Deviation 6.397 |
| GGF2 First Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | 4.75 percent change | Standard Deviation 8.18 |
| GGF2 Second Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | 5.00 percent change | Standard Deviation 7.528 |
| GGF2 Second Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | 0.78 percent change | Standard Deviation 8.418 |
| GGF2 Second Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | 5.00 percent change | Standard Deviation 10.863 |
| GGF2 Second Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | 8.50 percent change | Standard Deviation 10.472 |
| GGF2 Third Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | 2.50 percent change | Standard Deviation 5.196 |
| GGF2 Third Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | 2.00 percent change | Standard Deviation 4.546 |
| GGF2 Third Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | 0.75 percent change | Standard Deviation 4.031 |
| GGF2 Third Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | 4.00 percent change | Standard Deviation 2.449 |
| GGF2 Fourth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | 4.23 percent change | Standard Deviation 8.328 |
| GGF2 Fourth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | 4.25 percent change | Standard Deviation 4.272 |
| GGF2 Fourth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | 8.00 percent change | Standard Deviation 2 |
| GGF2 Fourth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | 7.25 percent change | Standard Deviation 8.77 |
| GGF2 Fifth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | 4.50 percent change | Standard Deviation 7.724 |
| GGF2 Fifth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | 5.75 percent change | Standard Deviation 2.5 |
| GGF2 Fifth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | -1.25 percent change | Standard Deviation 4.992 |
| GGF2 Fifth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | 2.13 percent change | Standard Deviation 5.36 |
| GGF2 Sixth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | 5.33 percent change | Standard Deviation 8.083 |
| GGF2 Sixth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | 9.00 percent change | Standard Deviation 5.598 |
| GGF2 Sixth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | 12.00 percent change | Standard Deviation 5.099 |
| GGF2 Sixth Escalated Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | 11.55 percent change | Standard Deviation 10.007 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | 3 Months | 15.00 percent change | Standard Deviation 13 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 28 | 10.00 percent change | Standard Deviation 7.55 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 14 | 7.10 percent change | Standard Deviation 8.627 |
| GGF2 Seventh Escalataed Dose | Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF) | Day 8 | 4.33 percent change | Standard Deviation 3.055 |