Recruitment

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 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
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.

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 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
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.

Locations

London, St George's University of London, SW17 0RE
London, St George's University of London, SW17 0RE

Tracking Information

NCT #
NCT02083666
Collaborators
Richmond Pharmacology Limited
Investigators
Study Director: Erik Brouwer, MD Swedish Orphan Biovitrum AB (publ)