Ulcerative ColitisPhase 1NCT01831427
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis
A Phase 1 study testing Andecaliximab in people with Ulcerative Colitis, run by Gilead Sciences at 16 sites in 7 countries.
Trial summary
The primary objectives of this study are as follows: To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities To assess the pharmacokinetics… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Andecaliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 28 Mar 2013to 6 Feb 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, 18 to 65 years of age
- Negative pregnancy test at screening
- Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
- Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
- Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
- Serum creatinine ≤ 1.5 times the ULN
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- Hemoglobin ≥ 10 grams per deciliter (g/dL) (both males and females)
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1,500 milli meters [mm]^3)
- Platelets ≥ 100 x 10^9/L.
Who cannot join
- Pregnant or lactating females
- Exhibit severe UC/ clinically significant active infection
- Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
- Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
- Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
- Crohn's disease or indeterminate colitis
Show all 11Show fewer
- History of colectomy, partial colectomy, or dysplasia on biopsy
- Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
- Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or Certolizumab within 8 weeks of randomization
- Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the Investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
United States6 sites
Ehrhardt Clinical Research, LLC
Belton, Missouri, 64012
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Clinical Research Institute of Michigan
Chesterfield Township, MI 48047, Michigan, 48047
Community Research
Cincinnati, Ohio, 45255
Duke University Medical Center
Durham, North Carolina, 27710
Delta Research Partners LLC
Monroe, Louisiana, 71201
Hungary3 sites
Drug Research Centre
Balatonfüred, 8230
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, Pest County, 1083
Clinical Pharma Center of Kenezy Gyula Korhaz Rendelointezet
Debrecen, Hajdú-Bihar, 4031
Canada2 sites
LHSC University Campus
London, Ontario, N6A 5A5
GIRI
Vancouver, British Columbia, V6Z 2K5
Netherlands2 sites
Academic Medical Center
Amsterdam, 1105 AZ
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX
About this study
Official title: A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis
The primary objectives of this study are as follows:
- To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities
- To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with moderate to severe UC.
Read the detailed description
The study will test the safety of the drug. Participants will be given different concentrations of the drug in Cohorts, starting from a lower dose to a higher dose.
Single-Dose Treatment:
A thorough assessment of safety and tolerability will be performed before escalating to the next higher dose. For example, the first 2 participants will be dosed in a staggered fashion 24 hours apart. Provided that there are no significant safety signals up to 24 hours post-dose for the first 2 participants, the remaining 4 participants will be dosed. A thorough assessment of safety and tolerability (through Day 14 post-dose) will be performed by the safety review committee before escalating to the next higher dose. Participants enrolled in a SAD cohort will be eligible to participate in a MAD or adaptive MAD cohort if eligibility criteria are met.
Multiple-Dose Treatment:
This design follows the same set-up as the Single-Dose Treatment. Dosing will not commence in the first MAD cohort until safety data from the second dose level SAD cohort has been reviewed through Day 15. Successive MAD cohorts will only be dosed after safety data from the previous, lower dose MAD cohort through Day 43 and the next higher dose SAD cohort through Day 15, have been reviewed by the safety review committee. An additional Adaptive MAD cohort will explore a subcutaneous dosing of andecaliximab 150 mg prefilled syringe once a week for 5 weeks.
- Conditions
- Ulcerative Colitis
- Being tested
- Andecaliximab, Placebo to match Andecaliximab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndecaliximabDrug
Also called GS-5745
Andecaliximab administered by intravenous (IV) infusion or subcutaneous (SC) injection
Placebo to match AndecaliximabDrug
Placebo to match andecaliximab administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Andecaliximab 0.3 mg/kg IV single ascending dose (SAD) | Experimental | Participants will receive andecaliximab 0.3 milligrams per kilogram (mg/kg) on Day 1. Receives: Drug: Andecaliximab |
| Andecaliximab 1.0 mg/kg IV (SAD) | Experimental | Participants will receive andecaliximab 1.0 mg/kg on Day 1. Receives: Drug: Andecaliximab |
| Andecaliximab 2.5 mg/kg IV (SAD) | Experimental | Participants will receive andecaliximab 2.5 mg/kg on Day 1. Receives: Drug: Andecaliximab |
| Andecaliximab 5.0 mg/kg IV (SAD) | Experimental | Participants will receive andecaliximab 5.0 mg/kg on Day 1. Receives: Drug: Andecaliximab |
| Placebo Pooled (SAD) | Placebo comparator | Participants will receive placebo on Day 1. Receives: Drug: Placebo to match Andecaliximab |
| Andecaliximab 0.3 mg/kg IV multiple ascending doses (MAD) | Experimental | Participants will receive andecaliximab 0.3 mg/kg on Days 1, 15, and 29. Receives: Drug: Andecaliximab |
| Andecaliximab 1.0 mg/kg IV (MAD) | Experimental | Participants will receive andecaliximab 1.0 mg/kg on Days 1, 15, and 29. Receives: Drug: Andecaliximab |
| Andecaliximab 2.5 mg/kg IV (MAD) | Experimental | Participants will receive andecaliximab 2.5 mg/kg on Days 1, 15, and 29. Receives: Drug: Andecaliximab |
| Andecaliximab 5.0 mg/kg IV (MAD) | Experimental | Participants will receive andecaliximab 5.0 mg/kg on Days 1, 15, and 29. Receives: Drug: Andecaliximab |
| Andecaliximab 150 mg SC (Adaptive MAD) | Experimental | Participants will receive andecaliximab 150 mg on Days 1, 8, 15, 22, and 29. Receives: Drug: Andecaliximab |
| Placebo Pooled (MAD) | Placebo comparator | Participants will receive placebo on Days 1, 15, and 29. Receives: Drug: Placebo to match Andecaliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events (TEAEs) (SAD/MAD)
TEAEs are any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Measured: SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days
Pharmacokinetic (PK) Parameter: Cmax (SAD)
Cmax is defined as the maximum concentration of drug.
Measured: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43
PK Parameter: Cmax (MAD)
Cmax is defined as the maximum concentration of drug over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.
Measured: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Days 1 and 29, Predose on Days 8 and 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Days 1, and 29, Predose on Days 8 and 36
PK Parameter: Ctau (MAD)
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Day 29; Predose on Day 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Day 29; Predose on Day 36
PK Parameter: AUCinf (SAD)
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Measured: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43
PK Parameter: AUCtau (MAD)
AUCtau is defined as the area under the plasma concentration versus time curve over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.
Measured: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Days 1 and 29; Predose on Days 8 and 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Days 1, and 29; Predose on Days 8 and 36
PK Parameter: AUClast (SAD)
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last observable concentration.
Measured: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study start28 Mar 2013
- Primary completion5 Jan 2015
- Study completion6 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831427
- Sponsor's protocol ID
- GS-US-326-0101
- Other IDs
- 2013-000305-23
- Status last verified
- Jan 2021
- First submitted
- 8 Apr 2013
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bhandari BR, Fogel R, Onken J, Yen EH, Kanwar B, Subramanian GM, McHutchison GJ, et al. Safety and Efficacy of GS-5745 an Anti-Matrix Metalloproteinase 9 (MMP) Monoclonal Antibody in Patients with Moderately to Severely Active Ulcerative Colitis. Gastroenterology 2015;148 (4): S-1196.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01831427
- Acronym / sponsor ID
- GS-US-326-0101
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 5 Jan 2015 (actual)
- Study completion
- 6 Feb 2015 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are as follows:
- To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities
- To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with moderate to severe UC.
Detailed description
The study will test the safety of the drug. Participants will be given different concentrations of the drug in Cohorts, starting from a lower dose to a higher dose.
Single-Dose Treatment:
A thorough assessment of safety and tolerability will be performed before escalating to the next higher dose. For example, the first 2 participants will be dosed in a staggered fashion 24 hours apart. Provided that there are no significant safety signals up to 24 hours post-dose for the first 2 participants, the remaining 4 participants will be dosed. A thorough assessment of safety and tolerability (through Day 14 post-dose) will be performed by the safety review committee before escalating to the next higher dose. Participants enrolled in a SAD cohort will be eligible to participate in a MAD or adaptive MAD cohort if eligibility criteria are met.
Multiple-Dose Treatment:
This design follows the same set-up as the Single-Dose Treatment. Dosing will not commence in the first MAD cohort until safety data from the second dose level SAD cohort has been reviewed through Day 15. Successive MAD cohorts will only be dosed after safety data from the previous, lower dose MAD cohort through Day 43 and the next higher dose SAD cohort through Day 15, have been reviewed by the safety review committee. An additional Adaptive MAD cohort will explore a subcutaneous dosing of andecaliximab 150 mg prefilled syringe once a week for 5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Andecaliximab 0.3 mg/kg IV single ascending dose (SAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 0.3 milligrams per kilogram (mg/kg) on Day 1. |
| Andecaliximab 1.0 mg/kg IV (SAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 1.0 mg/kg on Day 1. |
| Andecaliximab 2.5 mg/kg IV (SAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 2.5 mg/kg on Day 1. |
| Andecaliximab 5.0 mg/kg IV (SAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 5.0 mg/kg on Day 1. |
| Placebo Pooled (SAD) | Placebo comparator | Drug: Placebo to match AndecaliximabParticipants will receive placebo on Day 1. |
| Andecaliximab 0.3 mg/kg IV multiple ascending doses (MAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 0.3 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 1.0 mg/kg IV (MAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 1.0 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 2.5 mg/kg IV (MAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 2.5 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 5.0 mg/kg IV (MAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 5.0 mg/kg on Days 1, 15, and 29. |
| Andecaliximab 150 mg SC (Adaptive MAD) | Experimental | Drug: AndecaliximabParticipants will receive andecaliximab 150 mg on Days 1, 8, 15, 22, and 29. |
| Placebo Pooled (MAD) | Placebo comparator | Drug: Placebo to match AndecaliximabParticipants will receive placebo on Days 1, 15, and 29. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female, 18 to 65 years of age
- Negative pregnancy test at screening
- Documented diagnosis of UC with a minimum disease extent of 15 centimeters (cm) from the anal verge
- Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD cohorts
- Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] ≤ 2 times the upper limit of the normal range [ULN])
Key exclusion criteria (11 listed)
- Pregnant or lactating females
- Exhibit severe UC/ clinically significant active infection
- Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone
- Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP, Azathioprine), or oral 5-aminosalicylate (5-ASA) compounds within 30 days of Baseline
- Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior to randomization
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 |
|---|---|---|
| AndecaliximabAlso: GS-5745Andecaliximab administered by intravenous (IV) infusion or subcutaneous (SC) injection | Drug | Andecaliximab 0.3 mg/kg IV multiple ascending doses (MAD), Andecaliximab 0.3 mg/kg IV single ascending dose (SAD), Andecaliximab 1.0 mg/kg IV (MAD), Andecaliximab 1.0 mg/kg IV (SAD), Andecaliximab 150 mg SC (Adaptive MAD), Andecaliximab 2.5 mg/kg IV (MAD), Andecaliximab 2.5 mg/kg IV (SAD), Andecaliximab 5.0 mg/kg IV (MAD), Andecaliximab 5.0 mg/kg IV (SAD) |
| Placebo to match AndecaliximabPlacebo to match andecaliximab administered by IV infusion | Drug | Placebo Pooled (MAD), Placebo Pooled (SAD) |
Primary outcome
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events (TEAEs) (SAD/MAD)
Time frame: SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days
TEAEs are any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Pharmacokinetic (PK) Parameter: Cmax (SAD)
Time frame: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43
Cmax is defined as the maximum concentration of drug.
PK Parameter: Cmax (MAD)
Time frame: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Days 1 and 29, Predose on Days 8 and 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Days 1, and 29, Predose on Days 8 and 36
Cmax is defined as the maximum concentration of drug over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.
PK Parameter: Ctau (MAD)
Time frame: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Day 29; Predose on Day 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Day 29; Predose on Day 36
Ctau is defined as the observed drug concentration at the end of the dosing interval.
PK Parameter: AUCinf (SAD)
Time frame: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
PK Parameter: AUCtau (MAD)
Time frame: MAD Cohorts: Predose and 1, 2, and 6 hours postdose on Days 1 and 29; Predose on Days 8 and 36; Adaptive MAD Cohort: Predose and 6 hours postdose on Days 1, and 29; Predose on Days 8 and 36
AUCtau is defined as the area under the plasma concentration versus time curve over the dosing interval. Data for Day 1 was based on the data collected from Day 1 through Day 8. Data for Day 29 was based on the data collected from Day 29 through Day 36.
PK Parameter: AUClast (SAD)
Time frame: Predose and 1, 2, and 6 hours postdose on Day 1; Days 2, 3, 8, 15, 29, and 43
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last observable concentration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationBhandari BR, Fogel R, Onken J, Yen EH, Kanwar B, Subramanian GM, McHutchison GJ, et al. Safety and Efficacy of GS-5745 an Anti-Matrix Metalloproteinase 9 (MMP) Monoclonal Antibody in Patients with Moderately to Severely Active Ulcerative Colitis. Gastroenterology 2015;148 (4): S-1196.
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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.
Gilead Study Director study director
Gilead Sciences
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Andecaliximab in people with Ulcerative Colitis, run by Gilead Sciences at 16 sites in 7 countries.
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 9 inclusion and 11 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Hungary, Canada, Netherlands, Belgium and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events (TEAEs) (SAD/MAD) (time frame: SAD Cohorts: First dose date (Day 1) plus 30 days, MAD/Adaptive MAD Cohort: First dose date up to last dose date (Maximum: Day 29) plus 30 days). The study lists 7 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 NCT01831427, 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 Feb 2021.