AM1476/Placebo Study in Healthy Subjects

Sponsor

AnaMar AB (Industry)

Overall Status

Completed

CT.gov ID

NCT04691115

Collaborator

Covance (Industry)

Enrollment

Location

Arms

13.3

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase I, Double-blind AM1476/Placebo Study in Healthy Subjects

Condition or Disease	Intervention/Treatment	Phase
Safety Tolerability	Drug: AM1476 - Placebo	Phase 1

Detailed Description

Double-blind, randomised, placebo-controlled, single- and multiple-oral dose study conducted in 2 parts, for evaluation of AM1476.

Part A will comprise a single-ascending dose, sequential-group design incorporating a single-group, 2-period crossover arm incorporating a food-effect evaluation. Overall, 48 subjects will be studied in 6 groups, with each group consisting of 8 subjects.

Part B will comprise a multiple-ascending dose, sequential-group design. Overall, 24 subjects will be studied in 3 groups, with each group consisting of 8 subjects.

The primary objective of the study is to determine the safety and tolerability of single- and multiple-oral doses of AM1476 in healthy subjects.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

SAD part: sentinel dosing for 6 groups divided into 2 cohorts. MAD part: 3 groups Each group consists of 8 subjects, 6 will receive AM1476 and 2 will receive placebo.SAD part: sentinel dosing for 6 groups divided into 2 cohorts. MAD part: 3 groups Each group consists of 8 subjects, 6 will receive AM1476 and 2 will receive placebo.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

AM1476 - A Phase I, Double-blind, Placebo-controlled, Single- and Multiple-oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects

Actual Study Start Date :

Dec 16, 2020

Actual Primary Completion Date :

Jan 26, 2022

Actual Study Completion Date :

Jan 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active AM1476 AM1476 will be administered as capsules in an escalating manner	Drug: AM1476 - Placebo Oral drug administration
Experimental: Placebo Comparator will be administered as capsules	Drug: AM1476 - Placebo Oral drug administration

Arm

Intervention/Treatment

Experimental: Active AM1476

AM1476 will be administered as capsules in an escalating manner

Drug: AM1476 - Placebo

Oral drug administration

Experimental: Placebo

Comparator will be administered as capsules

Drug: AM1476 - Placebo

Oral drug administration

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Through study completion, an average of 7 weeks]
Incidence of Laboratory Abnormalities [Through study completion, an average of 7 weeks]
Incidence of ECG Abnormalities [Through study completion, an average of 7 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males or females, of any race, between 18 and 60 years of age, inclusive.
A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
In good health, no clinically significant findings from history, examination.
Females will not be pregnant or lactating,
Females of childbearing potential and males agree to use contraception.
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

Significant history or clinical manifestation of any disorder.
History of significant hypersensitivity, intolerance, or allergy.
History of stomach or intestinal surgery or resection.
Positive hepatitis panel and/or positive human immunodeficiency virus test.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit	Leeds		United Kingdom	LS2 9LH

Sponsors and Collaborators

AnaMar AB
Covance

Investigators

Principal Investigator: Ashley Brooks, MD, MBChB, Covance

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AnaMar AB

ClinicalTrials.gov Identifier:

NCT04691115

Other Study ID Numbers:

1476-291-001

First Posted:

Dec 31, 2020

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 16, 2022