HealthyPhase 1NCT02309762
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB825 in Healthy Volunteers
A Phase 1 study testing FB825 in people with Healthy, run by Fountain Biopharma Inc..
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FB825
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Feb 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is male or female between 18 and 55 years of age, inclusive.
- All female subjects must have a negative serum pregnancy test at screening and on Day -1.
- The subject has a body weight ≥50 kg at screening and a body mass index of 18 to 30 kg/m2, inclusive.
- The subject has a good health condition based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
- The subject has a negative urine drug screen for alcohol, cotinine.
Who cannot join
- Female subjects who are pregnant or lactating.
- The subject has a past history of heart arrhythmias.
- The subject has history of clinically significant diseases.
- The subject has any history of a previous anaphylactic reaction.
- Use of prescribed medication within 6 months of Day -1.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Ascending Intravenous Doses of FB825
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825
- Conditions
- Healthy
- Being tested
- FB825, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB825Drug
FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection
PlaceboDrug
Solution containing no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| FB825 | Experimental | 6 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg Receives: Drug: FB825 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse events (AE)
Measured: Up to day140
Clinical laboratory test results (hematology, coagulation, serum chemistry[including liver function tests], and urinalysis)
Measured: Up to day140
Vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and oral body temperature)
Measured: Up to day140
12-lead ECG results
Measured: Up to day140
Physical examination findings
Measured: Up to day140
Secondary outcomes (3)
Composite of PK parameters
Blood will be collected for the determination of serum FB825 concentrations, Cmax, Tmax, AUC, and terminal half-life.These parameters will be determined using non-compartmental methods.
Measured: Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose
Total IgE serum concentrations
Blood will be collected to measure serum IgE concentrations.
Measured: pre-dose, 5, 14, 29, 85, and 140 day post-dose
Immunogenicity (Anti-FB825 antibody in serum)
Blood will be collected to measure Immunogenicity.
Measured: pre-dose, 5, 14, 29, 85, and 140 day post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fountain Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309762
- Sponsor's protocol ID
- FB825CLCT01
- Status last verified
- Feb 2016
- First submitted
- 14 Nov 2014
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Ascending Intravenous Doses of FB825
- ClinicalTrials.gov ID
- NCT02309762
- Acronym / sponsor ID
- FB825CLCT01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fountain Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Dec 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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single-ascending IV doses of FB825
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FB825 | Experimental | Drug: FB8256 cohorts of subjects are planned to be dosed by IV injection, with single- ascending doses ranging from 0.003 - 10 mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject is male or female between 18 and 55 years of age, inclusive.
- All female subjects must have a negative serum pregnancy test at screening and on Day -1.
- The subject has a body weight ≥50 kg at screening and a body mass index of 18 to 30 kg/m2, inclusive.
- The subject has a good health condition based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
- The subject has a negative urine drug screen for alcohol, cotinine.
Key exclusion criteria (5 listed)
- Female subjects who are pregnant or lactating.
- The subject has a past history of heart arrhythmias.
- The subject has history of clinically significant diseases.
- The subject has any history of a previous anaphylactic reaction.
- Use of prescribed medication within 6 months of Day -1.
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 |
|---|---|---|
| FB825FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection | Drug | FB825 |
| PlaceboSolution containing no active ingredients | Drug | Placebo |
Primary outcome
Number of Participants with Adverse events (AE)
Time frame: Up to day140
Clinical laboratory test results (hematology, coagulation, serum chemistry[including liver function tests], and urinalysis)
Time frame: Up to day140
Vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and oral body temperature)
Time frame: Up to day140
12-lead ECG results
Time frame: Up to day140
Physical examination findings
Time frame: Up to day140
3 secondary outcomes
Composite of PK parameters
Time frame: Pre-dose, 2, 3, 5, 14, 29, 85, and 140 day post-dose
Total IgE serum concentrations
Time frame: pre-dose, 5, 14, 29, 85, and 140 day post-dose
Immunogenicity (Anti-FB825 antibody in serum)
Time frame: pre-dose, 5, 14, 29, 85, and 140 day post-dose
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 4 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FB825 in people with Healthy, run by Fountain Biopharma Inc..
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 5 inclusion and 5 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Number of Participants with Adverse events (AE) (time frame: Up to day140). The study lists 5 primary outcomes in all. 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 4 Feb 2016.