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

Applied Molecular Transport52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

AMT-101DRUG

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

PlacebosDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

LLC ARENSIA Exploratory Medicine

Tbilisi, Georgia

Charité Research Organisation GmbH

Berlin, Germany

ICS ARENSIA Exploratory Medicine SRL

Chisinau, Moldova

Medical Center of Harmoniya krasy, Department of clinical trials

Kyiv, Ukraine

Outcomes

Primary Outcomes

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.

Time frame: 14 days

Secondary Outcomes

Maximum plasma concentration (CMax)

To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.

Time frame: 14 days

Pharmacodynamics

To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.

Time frame: 14 days

Data from ClinicalTrials.gov

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