Healthy VolunteerPhase 1NCT01480310
Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers
A Phase 1 study testing MCAF5352A in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in Canada.
Trial summary
This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study site in Canada. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MCAF5352A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jun 2012
- 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
- Total body weight between 45 and 110 kg
- Vital signs within the following ranges: oral body temperature of 35°C to 37.5°C, systolic blood pressure of 90 to 140 mmHg, diastolic blood pressure of 50 to 90 mmHg, and pulse rate of 45 to 100 bpm
- Laboratory test parameters within normal reference ranges of the safety laboratory
- Female subjects: Willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug. Reliable forms of contraception include oral hormonal contraceptives, patch hormonal contraceptives, vaginal ring, intrauterine device, physical double-barrier methods, surgical hysterectomy, or vasectomy by male partner.
Who cannot join
- Pregnant or lactating women
- Administration of a live, attenuated vaccine within 30 days before Day 1 or anticipation that such a live attenuated vaccine will be required within 100 days of Day 1
- Subjects may receive influenza vaccination only during influenza season (approximately October to March). Subjects must not receive live attenuated influenza vaccine within 30 days prior to Day 1 or at any time during the study.
- Any major illness within 30 days prior to Day 1
- Clinically significant illness requiring treatment within 14 days prior to Day 1
- History of clinically significant ECG abnormalities or a known family history of cardiac conduction system disease
Show all 19Show fewer
- Positive test results indicating current or past infection with human immunodeficiency virus (HIV-1 or 2), hepatitis B virus (hepatitis B surface antigen [HBsAg], hepatitis B core antibody [anti-HBc]), or hepatitis C virus (HCV)
- Positive screening test for latent mycobacterial infection within the 2 months preceding Day 1 without evidence of a completed course of anti-tubercular therapy or previous BCG vaccination
- History of significant chronic or recurrent infections
- History of clinically significant drug allergy and/or a known hypersensitivity to protein therapeutics or formulation components or a related drug
- History of alcohol or drug abuse within 12 months prior to Day 1, or evidence of such abuse as indicated by the specific screening laboratory tests results, or alcohol consumption of more than 14 units of alcohol per week
- Positive breathalyzer for alcohol or urine screen results for drugs of abuse, or prescription medications
- Subjects who have previously received the study drug
- Participation in a clinical trial within 4 weeks before Day 1 or use of any experimental or biologic therapy within the 12 weeks prior to Day 1 or within 5 half-lives of the product, whichever is greater
- Use of prescription drugs within 14 days prior to Day 1 or during the study, except for hormonal contraceptives or hormone replacement therapy
- Use of over-the-counter (OTC) medication within 7 days prior to Day 1 or during the study. Medications such as acetaminophen and ibuprofen and routinely-taken dietary supplements, including vitamins and herbal supplements are allowed at the discretion of the investigator and provided that the medication in question has no discernible impact on the study.
- Donation of plasma within 7 days prior to Day 1. Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to Day 1.
- Lack of peripheral venous access
- Known history of mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ia, Single-Center, Randomized, Placebo-Controlled, Double-Blind, Single Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers
This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study site in Canada.
- Conditions
- Healthy Volunteer
- Being tested
- MCAF5352A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCAF5352ADrug
may receive up to 3 subcutaneous doses of MCAF5352A
PlaceboDrug
may receive up to 3 subcutaneous doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MCAF5352A |
| B | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: up to approximately 100 days
Secondary outcomes (4)
Pharmacokinetic: maximum serum concentration (Cmax)
Measured: up to approximately 100 days
Pharmacokinetic: time to maximum serum concentration (tmax)
Measured: up to approximately 100 days
Pharmacokinetic: apparent clearance (CL/F)
Measured: up to approximately 100 days
Pharmacokinetic: Terminal half-life (t½)
Measured: up to approximately 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480310
- Sponsor's protocol ID
- GA27909
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Single-Center, Randomized, Placebo-Controlled, Double-Blind, Single Ascending-Dose Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of Subcutaneous MCAF5352A in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01480310
- Acronym / sponsor ID
- GA27909
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Nov 2011 (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.
This is a Phase Ia, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in male and female healthy volunteers, aged 18-55 years, enrolled at a single study site in Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MCAF5352A |
| B | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Total body weight between 45 and 110 kg
- Vital signs within the following ranges: oral body temperature of 35°C to 37.5°C, systolic blood pressure of 90 to 140 mmHg, diastolic blood pressure of 50 to 90 mmHg, and pulse rate of 45 to 100 bpm
- Laboratory test parameters within normal reference ranges of the safety laboratory
- Female subjects: Willing to use two effective methods of contraception from screening to a minimum of 4 months after the last dose of study drug. Reliable forms of contraception include oral hormonal contraceptives, patch hormonal contraceptives, vaginal ring, intrauterine device, physical double-barrier methods, surgical hysterectomy, or vasectomy by male partner.
Key exclusion criteria (19 listed)
- Pregnant or lactating women
- Administration of a live, attenuated vaccine within 30 days before Day 1 or anticipation that such a live attenuated vaccine will be required within 100 days of Day 1
- Subjects may receive influenza vaccination only during influenza season (approximately October to March). Subjects must not receive live attenuated influenza vaccine within 30 days prior to Day 1 or at any time during the study.
- Any major illness within 30 days prior to Day 1
- Clinically significant illness requiring treatment within 14 days prior to 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 |
|---|---|---|
| MCAF5352Amay receive up to 3 subcutaneous doses of MCAF5352A | Drug | A |
| Placebomay receive up to 3 subcutaneous doses of placebo | Drug | B |
Primary outcome
Incidence of adverse events
Time frame: up to approximately 100 days
4 secondary outcomes
Pharmacokinetic: maximum serum concentration (Cmax)
Time frame: up to approximately 100 days
Pharmacokinetic: time to maximum serum concentration (tmax)
Time frame: up to approximately 100 days
Pharmacokinetic: apparent clearance (CL/F)
Time frame: up to approximately 100 days
Pharmacokinetic: Terminal half-life (t½)
Time frame: up to approximately 100 days
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 2 Nov 2016.
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Screening Protocol
Pain
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.
Clinical Trials study director
Genentech, Inc.
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 MCAF5352A in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in Canada.
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 4 inclusion and 19 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 2 Nov 2016. 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 Canada. 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?
Incidence of adverse events (time frame: up to approximately 100 days). 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 2 Nov 2016.