Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 80
Inclusion Criteria
- 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.
- 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.
- Females of non-childbearing potential or males
- 18 to 45 years of age
Exclusion Criteria
- 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.
- Clinically significant disease
- Females of childbearing potential
- 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.
- Clinically significant disease
- Females of childbearing potential
Summary
- Conditions
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Both males and females
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 place...
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.
Inclusion Criteria
- 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.
- 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.
- Females of non-childbearing potential or males
- 18 to 45 years of age
Exclusion Criteria
- 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.
- Clinically significant disease
- Females of childbearing potential
- 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.
- Clinically significant disease
- Females of childbearing potential
Tracking Information
- NCT #
- NCT02083666
- Collaborators
- Richmond Pharmacology Limited
- Investigators
- Study Director: Erik Brouwer, MD Swedish Orphan Biovitrum AB (publ)
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