Healthy VolunteerPhase 1NCT02528903
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers
A Phase 1 study testing MHAB5553A in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in Canada.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MHAB5553A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2015to 26 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent form (ICF)
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- Weight 40-100 kg
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- Clinical laboratory evaluations should be within reference range for the test, unless deemed not clinically significant by the investigator and sponsor at screening
- Willing to abstain from using drugs of abuse while enrolled in the study
- Willing and able to comply with protocol-specified criteria in regard to contraceptive protection
- Able to comply with the study protocol, in the investigator's judgment
Who cannot join
- History or clinically significant manifestations of metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
- History of anaphylaxis, hypersensitivity or drug allergies, unless approved by the investigator and sponsor
- History or presence of an abnormal ECG, which, in the investigator's or sponsor's opinion, is clinically significant (including evidence of previous acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block)
- History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
- History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening
- Current tobacco smokers (positive history within 3 months before initiation of dosing on Day 1), or those with positive cotinine test at check-in
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- Positive drug screen at screening or at check-in
- Positive pregnancy test result at screening or Day -1 or breast feeding during the study
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe enrollment in and completion of the study
- Unwillingness to comply or other conditions that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.
- Conditions
- Healthy Volunteer
- Being tested
- MHAB5553A, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHAB5553ADrug
Single intravenous administration, at various doses, depending on the cohort
Matching placeboDrug
Single intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: MHAB5553A; Drug: Matching placebo |
| Cohort B | Experimental | Not described Receives: Drug: MHAB5553A; Drug: Matching placebo |
| Cohort C | Experimental | Not described Receives: Drug: MHAB5553A; Drug: Matching placebo |
| Cohort D | Experimental | Not described Receives: Drug: MHAB5553A; Drug: Matching placebo |
| Cohort E | Experimental | Not described Receives: Drug: MHAB5553A; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events, graded by severity
Measured: Until study discontinuation/termination, up to 120 days
Changes in vital signs during and following MHAB5553A administration
Measured: Throughout the study, up to 120 days
Changes in physical examination finding during and following MHAB5553A administration
Measured: Throughout the study, up to 120 days
Changes in clinical laboratory results during and following MHAB5553A administration
Measured: Throughout the study, up to 120 days
Changes in electrocardiogram (ECG) findings during and following MHAB5553A
Measured: Throughout the study, up to 120 days
Incidence of serum anti-MHAB5553A antibodies
Measured: Until study discontinuation/termination, up to 120 days
Secondary outcomes (8)
Maximum serum concentration (Cmax) of MHAB5553A
Measured: Up to 120 days
Time to Cmax (tmax) of MHAB5553A
Measured: Up to 120 days
Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A
Measured: Up to 120 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A
Measured: Up to 120 days
Clearance (CL) of MHAB5553A
Measured: Up to 120 days
Volume of distribution at steady-state (Vss) of MHAB5553A
Measured: Up to 120 days
Terminal elimination half-life (t1/2) of MHAB5553A
Measured: Up to 120 days
Mean Residence Time (MRT) of MHAB5553A
Measured: Up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start18 Aug 2015
- Primary completion26 Jan 2016
- Study completion26 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528903
- Sponsor's protocol ID
- GV29827
- Status last verified
- Sep 2019
- First submitted
- 17 Aug 2015
- Last updated
- 1 Oct 2019
- Results posted
- No
Publications
Lim JJ, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug.
PubMed 28559255
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02528903
- Acronym / sponsor ID
- GV29827
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 26 Jan 2016 (actual)
- Study completion
- 26 Jan 2016 (actual)
- First posted
- 19 Aug 2015 (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 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: MHAB5553A, Drug: Matching placebo |
| Cohort B | Experimental | Drug: MHAB5553A, Drug: Matching placebo |
| Cohort C | Experimental | Drug: MHAB5553A, Drug: Matching placebo |
| Cohort D | Experimental | Drug: MHAB5553A, Drug: Matching placebo |
| Cohort E | Experimental | Drug: MHAB5553A, Drug: Matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent form (ICF)
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- Weight 40-100 kg
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- Clinical laboratory evaluations should be within reference range for the test, unless deemed not clinically significant by the investigator and sponsor at screening
Key exclusion criteria (10 listed)
- History or clinically significant manifestations of metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
- History of anaphylaxis, hypersensitivity or drug allergies, unless approved by the investigator and sponsor
- History or presence of an abnormal ECG, which, in the investigator's or sponsor's opinion, is clinically significant (including evidence of previous acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block)
- History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
- History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening
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 |
|---|---|---|
| MHAB5553ASingle intravenous administration, at various doses, depending on the cohort | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
| Matching placeboSingle intravenous dose | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Incidence of adverse events, graded by severity
Time frame: Until study discontinuation/termination, up to 120 days
Changes in vital signs during and following MHAB5553A administration
Time frame: Throughout the study, up to 120 days
Changes in physical examination finding during and following MHAB5553A administration
Time frame: Throughout the study, up to 120 days
Changes in clinical laboratory results during and following MHAB5553A administration
Time frame: Throughout the study, up to 120 days
Changes in electrocardiogram (ECG) findings during and following MHAB5553A
Time frame: Throughout the study, up to 120 days
Incidence of serum anti-MHAB5553A antibodies
Time frame: Until study discontinuation/termination, up to 120 days
8 secondary outcomes
Maximum serum concentration (Cmax) of MHAB5553A
Time frame: Up to 120 days
Time to Cmax (tmax) of MHAB5553A
Time frame: Up to 120 days
Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A
Time frame: Up to 120 days
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A
Time frame: Up to 120 days
Clearance (CL) of MHAB5553A
Time frame: Up to 120 days
Volume of distribution at steady-state (Vss) of MHAB5553A
Time frame: Up to 120 days
Terminal elimination half-life (t1/2) of MHAB5553A
Time frame: Up to 120 days
Mean Residence Time (MRT) of MHAB5553A
Time frame: Up to 120 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 1 Oct 2019.
- Derived from this study: PubMed 28559255Lim JJ, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA. A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug.
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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
Hoffmann-La Roche
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 MHAB5553A 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 8 inclusion and 10 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 1 Oct 2019. 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, graded by severity (time frame: Until study discontinuation/termination, up to 120 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528903, which also lists 1 linked publication.
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 1 Oct 2019.