Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration

NCT02083666 | Terminated Phase 1

• 1 other identifier: SOBI002-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.

Conditions

Healthy

Keywords

Phase I; Dose cohorts; Escalating dose; Single dose; Multiple dose; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; volunteers

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration

  Safety will be evaluated by assessing all Adverse Events, vital signs, 12-lead ECGs, urine samples for determination of urinalysis variables and blood samples for determination of hematology, biochemistry and coagulation variables.

  Up to 13 weeks

Secondary Outcomes (3)

• Assessment of pharmacokinetics of SOBI002 through analysis of serum samples

  Up to 13 weeks

• Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity

  Up to 13 weeks

• Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies

  Up to 13 weeks

Study Arms (2)

SOBI002

EXPERIMENTAL

Single and repeated administration of different doses of test product

Drug: SOBI002

placebo

PLACEBO COMPARATOR

Single and repeated administration of placebo comparator

Drug: Placebo

Interventions

SOBI002 DRUG

Test Product

SOBI002

Placebo DRUG

Reference product

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females of non-childbearing potential or males
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead
• Richmond Pharmacology Limited: collaborator

Study Sites (1)

Richmond Pharmacology Ltd.

London, Saint George's University of London, SW17 0RE, United Kingdom

Location

Study Officials

• Erik Brouwer, MD

  Swedish Orphan Biovitrum AB (publ)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: March 11, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

GB (1)