HealthyPhase 1NCT02246855
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers
A Phase 1 study testing Gammaplex® (Human Normal Immunoglobulin) in people with Healthy, run by Bio Products Laboratory at 1 site in United Kingdom.
Trial summary
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gammaplex® (Human Normal Immunoglobulin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2004to Dec 2004
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria.
- Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
- Postmenopausal or surgically sterile female volunteers could be enrolled.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Pharmacology Research Unit (CPRU)
Level 7, Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ
About this study
Official title: A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).
- Conditions
- Healthy
- Being tested
- Gammaplex® (Human Normal Immunoglobulin)
- Keywords
- Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gammaplex® (Human Normal Immunoglobulin)Biological
| Study group | Role | What they receive |
|---|---|---|
| Vigam® Liquid infused at up to 3mL/min | Experimental | Gammaplex® (Human Normal Immunoglobulin) Receives: Biological: Gammaplex® (Human Normal Immunoglobulin) |
| Gammaplex® infused at up to 3mL/min | Experimental | Gammaplex® (Human Normal Immunoglobulin) Receives: Biological: Gammaplex® (Human Normal Immunoglobulin) |
| Gammaplex® infused at up to 6mL/min | Experimental | Gammaplex® (Human Normal Immunoglobulin) Receives: Biological: Gammaplex® (Human Normal Immunoglobulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters for serum immunoglobulin G (IgG)
Measured: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startAug 2004
- Primary completionDec 2004
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.
- 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
Sponsor and investigators
- Lead sponsor
- Bio Products Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Wessels, MBChB MBA, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246855
- Sponsor's protocol ID
- GMX03
- Status last verified
- Aug 2014
- First submitted
- 2 Sep 2014
- Last updated
- 27 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)
- ClinicalTrials.gov ID
- NCT02246855
- Acronym / sponsor ID
- GMX03
- Conditions
- Healthy
- Keywords
- Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 23 Sep 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 object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).
Study design
- Primary purpose
- Treatment
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vigam® Liquid infused at up to 3mL/min | Experimental | Biological: Gammaplex® (Human Normal Immunoglobulin)Gammaplex® (Human Normal Immunoglobulin) |
| Gammaplex® infused at up to 3mL/min | Experimental | Biological: Gammaplex® (Human Normal Immunoglobulin)Gammaplex® (Human Normal Immunoglobulin) |
| Gammaplex® infused at up to 6mL/min | Experimental | Biological: Gammaplex® (Human Normal Immunoglobulin)Gammaplex® (Human Normal Immunoglobulin) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria.
- Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.
- Postmenopausal or surgically sterile female volunteers could be enrolled.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Gammaplex® (Human Normal Immunoglobulin) | Biological | Gammaplex® infused at up to 3mL/min, Gammaplex® infused at up to 6mL/min, Vigam® Liquid infused at up to 3mL/min |
Primary outcome
PK parameters for serum immunoglobulin G (IgG)
Time frame: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
David Wessels, MBChB MBA principal investigator
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 Gammaplex® (Human Normal Immunoglobulin) in people with Healthy, run by Bio Products Laboratory 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 1 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: finished, as of the sponsor's last update on 27 Feb 2018. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PK parameters for serum immunoglobulin G (IgG) (time frame: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85). 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 27 Feb 2018.