Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
Full description
This is a double-blind, placebo-controlled, randomized within dose cohort single and repeated dose study with sequential dose escalation.
Eligible volunteers will be divided into dose cohorts and for each cohort, a new panel of 8 volunteers will be randomized to receive either SOBI002 (n=6) or placebo (n=2). SOBI002 will either be administered subcutaneously or intravenously.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Females of non-childbearing potential or males
- 18 to 45 years of age
- Judged by the Principal Investigator to be healthy on the basis of medical history and a pre-study physical examination including 12-lead electrocardiogram (ECG), 24-hour Holter ECG, vital signs and blood and urine laboratory assessments.
Exclusion criteria
- Females of childbearing potential
- Clinically significant disease
- Clinically significant abnormal laboratory, ECG, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission.
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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