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SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101 (AURIGA1)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AMT-101
Placebos
Sponsored by
Applied Molecular Transport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
  • 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)

Exclusion Criteria:

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

Sites / Locations

  • LLC ARENSIA Exploratory Medicine
  • Charité Research Organisation GmbH
  • ICS ARENSIA Exploratory Medicine SRL
  • Medical Center of Harmoniya krasy, Department of clinical trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMT-101

Placebo

Arm Description

AMT-101

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum plasma concentration (CMax)
To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.
Pharmacodynamics
To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.

Full Information

First Posted
May 23, 2019
Last Updated
October 26, 2020
Sponsor
Applied Molecular Transport
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1. Study Identification

Unique Protocol Identification Number
NCT04224857
Brief Title
SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101
Acronym
AURIGA1
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Molecular Transport

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomized to either receive AMT-101 or placebo
Masking
ParticipantInvestigator
Masking Description
matching placebo
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMT-101
Arm Type
Experimental
Arm Description
AMT-101
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AMT-101
Other Intervention Name(s)
no other name applicable
Intervention Description
Single or daily dosing at doses A, B, C, D, E, F
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
no other name applicable
Intervention Description
Single or daily dosing at doses A, B, C, D, E, F
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent adverse events (safety and tolerability)
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (CMax)
Description
To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.
Time Frame
14 days
Title
Pharmacodynamics
Description
To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Incidence of anti-drug antibodies against AMT-101
Description
Incidence of anti-drug antibodies against AMT-101 in healthy adult volunteers and subjects with UC.
Time Frame
14 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Healthy Male Volunteers for Single Dose portion only
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bittoo Kanwar, MD
Organizational Affiliation
Applied Molecular Transport
Official's Role
Study Director
Facility Information:
Facility Name
LLC ARENSIA Exploratory Medicine
City
Tbilisi
Country
Georgia
Facility Name
Charité Research Organisation GmbH
City
Berlin
Country
Germany
Facility Name
ICS ARENSIA Exploratory Medicine SRL
City
Chisinau
Country
Moldova, Republic of
Facility Name
Medical Center of Harmoniya krasy, Department of clinical trials
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101

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