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

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SOBI002 Following Subcutaneous and Intravenous Administration. A Double-blind, Placebo-controlled, Randomized Within Dose Cohort, Single and Repeated Dose-escalation Study in Healthy Volunteers

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02083666

Enrollment

Registered

2014-03-11

Start date

2013-12-31

Completion date

2015-02-28

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Detailed 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.

Interventions

DRUGSOBI002

Test Product

DRUGPlacebo

Reference product

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration	Up to 13 weeks	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.

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026