HealthyPhase 1NCT02083666
Safety and Tolerability of SOBI002 in Healthy Volunteers Following Single and Repeated Administration
A Phase 1 study testing SOBI002 in people with Healthy, run by Swedish Orphan Biovitrum at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SOBI002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Richmond Pharmacology Ltd.
London, Saint George's University of London, SW17 0RE
About this study
Official title: 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
The main purpose of this study is to assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated administration.
Read the 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.
- Conditions
- Healthy
- Being tested
- SOBI002, Placebo
- Keywords
- Phase I, Dose cohorts, Escalating dose, Single dose, Multiple dose, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOBI002Drug
Test Product
PlaceboDrug
Reference product
| Study group | Role | What they receive |
|---|---|---|
| SOBI002 | Experimental | Single and repeated administration of different doses of test product Receives: Drug: SOBI002 |
| placebo | Placebo comparator | Single and repeated administration of placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 13 weeks
Secondary outcomes (3)
Assessment of pharmacokinetics of SOBI002 through analysis of serum samples
Measured: Up to 13 weeks
Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity
Measured: Up to 13 weeks
Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2014
- Study completionFeb 2015
Why it stopped: Transient adverse events observed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Responsible party
- Sponsor
- Investigators
- Erik Brouwer, MD, Study director, Swedish Orphan Biovitrum AB (publ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083666
- Sponsor's protocol ID
- SOBI002-001
- Status last verified
- Jul 2015
- First submitted
- 15 Jan 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02083666
- Acronym / sponsor ID
- SOBI002-001
- Conditions
- Healthy
- Keywords
- Phase I, Dose cohorts, Escalating dose, Single dose, Multiple dose, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Transient adverse events observed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOBI002 | Experimental | Drug: SOBI002Single and repeated administration of different doses of test product |
| placebo | Placebo comparator | Drug: PlaceboSingle and repeated administration of placebo comparator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOBI002Test Product | Drug | SOBI002 |
| PlaceboReference product | Drug | placebo |
Primary outcome
To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration
Time frame: 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.
3 secondary outcomes
Assessment of pharmacokinetics of SOBI002 through analysis of serum samples
Time frame: Up to 13 weeks
Assessment of pharmacodynamics by assessing the inhibition of SOBI002 on hemolytic activity
Time frame: Up to 13 weeks
Assessment of the immungenicity of SOBI002 by measuring the occurence of anti-drug antibodies
Time frame: Up to 13 weeks
Results and safety
The study was stopped early (reason given: Transient adverse events observed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Brouwer, MD study director
Swedish Orphan Biovitrum AB (publ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOBI002 in people with Healthy, run by Swedish Orphan Biovitrum at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Transient adverse events observed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of SOBI002 in healthy volunteers following single and repeated adminstration (time frame: Up to 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.