Cohort1: dose level 1
|
Administration route |
subcutaneous injection |
Dosage |
20 mg, once every 4 weeks (Q4W) |
Pts |
48 |
Age |
Adult, Older_Adult |
Outcome |
Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -7(-16 to 3)%, in the Plasma Levels of Apolipoprotein B (apoB) is -3(-9 to 4). |
Adverse reactions |
7/48(Cardiac disorders; Gastrointestinal disorders; General disorders; Neoplasms benign, malignant and unspecified, incl cysts and polyps; Nervous system disorders) |
|
Cohort2: dose level 2
|
Administration route |
subcutaneous injection |
Dosage |
40 mg, once every 4 weeks (Q4W) |
Pts |
48 |
Age |
Adult, Older_Adult |
Outcome |
Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -26(-33 to -18)%, in the Plasma Levels of Apolipoprotein B (apoB) is -15(-20 to -10). |
Adverse reactions |
7/48(Cardiac disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Musculoskeletal and connective tissue disorders; Psychiatric disorders; Reproductive system and breast disorders) |
|
Cohort3: dose level 3
|
Administration route |
subcutaneous injection |
Dosage |
60 mg, once every 4 weeks (Q4W) |
Pts |
47 |
Age |
Adult, Older_Adult |
Outcome |
Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -16(-24 to -7)%, in the Plasma Levels of Apolipoprotein B (apoB) is -8(-14 to -2). |
Adverse reactions |
1/48(All-cause mortality); 7/47(Cardiac disorders; Injury, poisoning and procedural complications; Neoplasms benign, malignant and unspecified, incl cysts and polyps; Vascular disorders) |
|
Cohort4: dose level 4
|
Administration route |
subcutaneous injection |
Dosage |
20 mg, once every 2 weeks (Q2W) |
Pts |
48 |
Age |
Adult, Older_Adult |
Outcome |
Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -17(-25 to -8)%, in the Plasma Levels of Apolipoprotein B (apoB) is -9(-15 to -3). |
Adverse reactions |
3/48(Cardiac disorders; Gastrointestinal disorders; Metabolism and nutrition disorders) |
|
Cohort5: dose level 5
|
Administration route |
subcutaneous injection |
Dosage |
20 mg, once every 1 weeks (Q1W) |
Pts |
48 |
Age |
Adult, Older_Adult |
Outcome |
Geometric Mean (95% Confidence Interval) of Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) is -23(-31 to -14)%, in the Plasma Levels of Apolipoprotein B (apoB) is -16(-21 to -10). |
Adverse reactions |
1/48(All-cause mortality); 4/48(Infections and infestations; Injury, poisoning and procedural complications; Nervous system disorders; Psychiatric disorders; Surgical and medical procedures) |
|