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

NCT ID: NCT04224857

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-04-30

Brief Summary

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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

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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

1. naïve to anti-TNFα therapy or
2. have failed or demonstrated intolerance to anti-TNF-α therapy.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study participants will be randomized to either receive AMT-101 or placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
matching placebo

Study Groups

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AMT-101

AMT-101

Group Type EXPERIMENTAL

AMT-101

Intervention Type DRUG

Single or daily dosing at doses A, B, C, D, E, F

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Single or daily dosing at doses A, B, C, D, E, F

Interventions

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AMT-101

Single or daily dosing at doses A, B, C, D, E, F

Intervention Type DRUG

Placebos

Single or daily dosing at doses A, B, C, D, E, F

Intervention Type DRUG

Other Intervention Names

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no other name applicable no other name applicable

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Applied Molecular Transport

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bittoo Kanwar, MD

Role: STUDY_DIRECTOR

Applied Molecular Transport

Locations

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LLC ARENSIA Exploratory Medicine

Tbilisi, , Georgia

Site Status

Charité Research Organisation GmbH

Berlin, , Germany

Site Status

ICS ARENSIA Exploratory Medicine SRL

Chisinau, , Moldova

Site Status

Medical Center of Harmoniya krasy, Department of clinical trials

Kyiv, , Ukraine

Site Status

Countries

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Georgia Germany Moldova Ukraine

Other Identifiers

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AMT-101-001

Identifier Type: -

Identifier Source: org_study_id