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

Ulcerative Colitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224857
• Other study ID #: AMT-101-001
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2020
• Source: Applied Molecular Transport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• AMT-101
Single or daily dosing at doses A, B, C, D, E, F
• Placebos
Single or daily dosing at doses A, B, C, D, E, F

Locations

Country	Name	City	State
Georgia	LLC ARENSIA Exploratory Medicine	Tbilisi
Germany	Charité Research Organisation GmbH	Berlin
Moldova, Republic of	ICS ARENSIA Exploratory Medicine SRL	Chisinau
Ukraine	Medical Center of Harmoniya krasy, Department of clinical trials	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Applied Molecular Transport

Countries where clinical trial is conducted

Georgia,  Germany,  Moldova, Republic of,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of anti-drug antibodies against AMT-101	Incidence of anti-drug antibodies against AMT-101 in healthy adult volunteers and subjects with UC.	14 days
Primary	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.	14 days
Secondary	Maximum plasma concentration (CMax)	To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.	14 days
Secondary	Pharmacodynamics	To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.	14 days