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

Applied Molecular Transport50 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

AMT-126DRUG

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

PlaceboDRUG

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

Radioactive Tablet (Part 2 Only)OTHER

Single dose in two periods in Part 2 (optional)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

PART 1 \& 2 (Healthy Volunteers) 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.

Locations (1)

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Outcomes

Primary Outcomes

Incidence of Treatment-emergent adverse events (safety and tolerability)

Single ascending doses of AMT-126 in healthy adult volunteers by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v5.0

Time frame: 5 days

To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)

Qualitative scintigraphic data will be compiled using the following data points for analysis: tablet release (hh:mm), location of tablet release (anatomical location), gastric emptying and arrival times (hh:mm)

Time frame: 5 days

Secondary Outcomes

To assess pharmacokinetics of AMT-126 in healthy volunteers

Assess PK parameters (i.e. Cmax) as applicable for AMT-126

Time frame: 5 days

Data from ClinicalTrials.gov

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