SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2022-03-26

Brief Summary

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Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

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Detailed Description

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A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double-blinded (Part 1), Open Label (Part 2)

Study Groups

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AMT-126

oral AMT-126

Group Type EXPERIMENTAL

AMT-126

Intervention Type DRUG

Single or daily dosing at doses A, B, C, D, E, F; G, H, and I

Placebo

oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single or daily dosing at doses A, B, C, D, E, F; G,H, and I

Radioactive Tablet (Part 2 only)

oral radioactive tablet for scintigraphic analysis

Group Type OTHER

Radioactive Tablet (Part 2 Only)

Intervention Type OTHER

Single dose in two periods in Part 2 (optional)

Interventions

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AMT-126

Single or daily dosing at doses A, B, C, D, E, F; G, H, and I

Intervention Type DRUG

Placebo

Single or daily dosing at doses A, B, C, D, E, F; G,H, and I

Intervention Type DRUG

Radioactive Tablet (Part 2 Only)

Single dose in two periods in Part 2 (optional)

Intervention Type OTHER

Other Intervention Names

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no other name applicable no other name applicable no other name applicable

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and female subjects of NOCBP.
* Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
* A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
* Contraception requirements for male \& female subjects.

Exclusion Criteria

* Known hypersensitivity or allergy to AMT-126 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).
* Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
* Evidence of current SARS-CoV-2 or COVID infection.
* Women of child-bearing potential.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes