SAD/MAD Study in Healthy Subjects and Adults With UC to E... | NCT04224857

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

NCT04224857

Sponsor

Applied Molecular Transport

Status

Completed

Last Update Posted

Oct 28, 2020Actual

Enrollment

52Actual

Phase

Phase 1

Conditions

Ulcerative Colitis

Interventions

AMT-101
Placebos

Countries

Georgia
Germany
Moldova
Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

Jan 8, 2020

First Posted Date

Jan 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2020

Last Update Posted Date

Oct 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMT-101	Experimental	AMT-101	Drug: AMT-101
Placebo	Placebo Comparator	Placebo	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMT-101	Drug	Single or daily dosing at doses A, B, C, D, E, F	AMT-101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Maximum plasma concentration (CMax)	To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.	14 days
Pharmacodynamics	To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Healthy Male Volunteers for Single Dose portion only

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
LLC ARENSIA Exploratory Medicine		Tbilisi			Georgia
Charité Research Organisation GmbH

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases