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

NCT04224857 | Completed Phase 1 DMC

• 1 other identifier: AMT-101-001
• Study Type: interventional
• Target: 52
• Locations: 4 countries
• Sites: 4

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum plasma concentration (CMax)

  14 days

• Pharmacodynamics

  14 days

Other Outcomes (1)

• Incidence of anti-drug antibodies against AMT-101

  14 days

Study Arms (2)

AMT-101

EXPERIMENTAL

AMT-101

Drug: AMT-101

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebos

Interventions

AMT-101 DRUG

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

Also known as: no other name applicable

AMT-101

Placebos DRUG

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

Also known as: no other name applicable

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Healthy Male Volunteers for Single Dose portion only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Molecular Transport: lead

Study Sites (4)

LLC ARENSIA Exploratory Medicine

Tbilisi, Georgia

Location

Charité Research Organisation GmbH

Berlin, Germany

Location

ICS ARENSIA Exploratory Medicine SRL

Chisinau, Moldova

Location

Medical Center of Harmoniya krasy, Department of clinical trials

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bittoo Kanwar, MD

  Applied Molecular Transport

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study participants will be randomized to either receive AMT-101 or placebo

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: January 13, 2020
• Study Start: April 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

DE (1); UA (1); GE (1); MO (1)