Multiple Ascending Dose Study of SPC4955 in Healthy Subjects

Santaris Pharma

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: Saline 0.9%; Drug: SPC4955

Study type: Interventional

Funder types: Industry

Identifiers

NCT01365663

EudraCT 2010-024363-40

SPC4955-901

Details and patient eligibility

About

The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female subjects, age 18-65 years, inclusive.

2. BMI 18-33 kg/m2

3. Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:

   • LDL-C ≥3.24 mmol/L (≥125 mg/dL)
   • Triglycerides (fasted) <2.7mmol/L (<239 mg/dL)
   • ALT within normal limits

Exclusion criteria

1. Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
2. History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled
3. Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
4. Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study.
5. Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies.
6. Positive results on the following Screening laboratory tests: urine pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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18 participants in 6 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

0.25 mg/kg in Healthy Subjects

Treatment:

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Cohort 2

Experimental group

Description:

0.5 mg/kg in Healthy Subjects

Treatment:

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Cohort 3

Experimental group

Description:

1.0 mg/kg in Healthy Subjects

Treatment:

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Cohort 4

Experimental group

Description:

1.5 mg/kg in Healthy Subjects

Treatment:

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Cohort 5

Experimental group

Description:

2.0 mg/kg in Healthy Subjects

Treatment:

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Drug: SPC4955

Saline 0.9%

Placebo Comparator group

Treatment:

Drug: Saline 0.9%