Ulcerative ColitisPhase 1AURIGA1NCT04224857
SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101
A Phase 1 study testing AMT-101 in people with Ulcerative Colitis, run by Applied Molecular Transport at 4 sites in 4 countries.
Trial summary
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- AMT-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Apr 2019to 30 Apr 2020
- 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
- PART A (Healthy Volunteers)
- Male subject in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening
- Between 18 and 45 years of age, inclusive.
- Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).
- PART B (Adult Ulcerative Colitis)
- Male and Female patients 18 years and older
Show all 9Show fewer
- Documented diagnosis of UC for at least 3 months duration
- Stable mild to moderate UC, as defined by the following criteria: Total Mayo score (excluding PGA) at least 3 but not greater than 7:
- Patients must have failed or demonstrated intolerance to aminosalicylates (e.g., 5-aminosalicylic acid, mesalamine)
Who cannot join
- PART A and PART B
- Known hypersensitivity or allergy to AMT-101 or excipient contained in the drug formulation.
- Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
- PART B
- Clinical findings of Crohn's disease
- A prior history of surgery for UC
- Prior use of integrin antagonists (vedolizumab, natalizumab), JAK kinase inhibitors (tofacitinib), cyclosporin or tacrolimus
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Ukraine1 site
Medical Center of Harmoniya krasy, Department of clinical trials
Kyiv
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Read the detailed description
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance.
Patients may be
- naïve to anti-TNFα therapy or
- have failed or demonstrated intolerance to anti-TNF-α therapy.
- Conditions
- Ulcerative Colitis
- Being tested
- AMT-101, Placebos
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-101Drug
Also called no other name applicable
Single or daily dosing at doses A, B, C, D, E, F
PlacebosDrug
Also called no other name applicable
Single or daily dosing at doses A, B, C, D, E, F
| Study group | Role | What they receive |
|---|---|---|
| AMT-101 | Experimental | AMT-101 Receives: Drug: AMT-101 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent adverse events (safety and tolerability)
Single and multiple ascending doses of AMT-101 in healthy adult volunteers and patients with active UC by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v4.03 and Modified Mayo Score criteria.
Measured: 14 days
Secondary outcomes (2)
Maximum plasma concentration (CMax)
To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.
Measured: 14 days
Pharmacodynamics
To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Apr 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Model description
- Study participants will be randomized to either receive AMT-101 or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Molecular Transport
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bittoo Kanwar, MD, Study director, Applied Molecular Transport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224857
- Sponsor's protocol ID
- AMT-101-001
- Acronym
- AURIGA1
- Status last verified
- Oct 2020
- First submitted
- 23 May 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101
- ClinicalTrials.gov ID
- NCT04224857
- Acronym / sponsor ID
- AURIGA1 / AMT-101-001
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Applied Molecular TransportIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- 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.
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Detailed description
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance.
Patients may be
- naïve to anti-TNFα therapy or
- have failed or demonstrated intolerance to anti-TNF-α therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study participants will be randomized to either receive AMT-101 or placebo
| Arm | Type | Receives |
|---|---|---|
| AMT-101 | Experimental | Drug: AMT-101AMT-101 |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PART A (Healthy Volunteers)
- Male subject in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening
- Between 18 and 45 years of age, inclusive.
- Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).
- PART B (Adult Ulcerative Colitis)
Key exclusion criteria (7 listed)
- PART A and PART B
- Known hypersensitivity or allergy to AMT-101 or excipient contained in the drug formulation.
- Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
- PART B
- Clinical findings of Crohn's disease
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 |
|---|---|---|
| AMT-101Also: no other name applicableSingle or daily dosing at doses A, B, C, D, E, F | Drug | AMT-101 |
| PlacebosAlso: no other name applicableSingle or daily dosing at doses A, B, C, D, E, F | Drug | Placebo |
Primary outcome
Incidence of Treatment-emergent adverse events (safety and tolerability)
Time frame: 14 days
Single and multiple ascending doses of AMT-101 in healthy adult volunteers and patients with active UC by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v4.03 and Modified Mayo Score criteria.
2 secondary outcomes
Maximum plasma concentration (CMax)
Time frame: 14 days
Pharmacodynamics
Time frame: 14 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 28 Oct 2020.
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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.
Bittoo Kanwar, MD study director
Applied Molecular Transport
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMT-101 in people with Ulcerative Colitis, run by Applied Molecular Transport at 4 sites in 4 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 7 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 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia, Germany, Moldova, Ukraine. 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?
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 Treatment-emergent adverse events (safety and tolerability) (time frame: 14 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 28 Oct 2020.