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Follistatin 344

FS-344, Activin-Binding Protein, FST344

Quick Stats
Studies 2
Trials 73
Completed PHASE1 INTERVENTIONAL NCT03682484

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2). The primary purpose of this study is to evaluate the safety and tolerability of single ascending oral doses in Part 1 (SAD Including Evaluation of Food Effect) and multiple ascending oral doses in Part 2 (MAD) of MA-0211 in healthy adult participants. This study will also evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending and multiple ascending oral doses of MA-0211 in healthy adult participants. In addition, this study will evaluate the effect of a single oral dose of MA-0211 on the QT interval using Fridericia's Correction (QTcF); determine the effect of food on the PK of a single oral dose of MA-0211 as well as evaluate the effect of multiple oral doses of MA-0211 on the QTcF.

Detailed Description

After a screening period of up to 29 days prior to study drug administration, eligible participants will be residential for a single period of 6 days/5 nights in Part 1 and 19 days/18 nights in Part 2 . Participants will be admitted to the clinical unit on day 2.

Interventions

Name: MA-0211
Type: DRUG
Description: oral
Name: Placebo
Type: DRUG
Description: oral

Primary Outcomes

Measure: Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs)
TimeFrame: Up to day 26
Description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measure: Number of participants with vital sign abnormalities and /or adverse events (AEs)
TimeFrame: Up to day 26
Description: Number of participants with potentially clinically significant vital sign values.
Measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs)
TimeFrame: Up to day 26
Description: Number of participants with potentially clinically significant laboratory values.
Measure: Safety assessed by routine 12- lead electrocardiogram (ECG)
TimeFrame: Up to day 26
Description: The overall conclusion of the routine ECG will be recorded as normal, abnormal not clinically significant, or abnormal clinically significant.
Measure: Safety assessed by continuous 12- lead electrocardiogram (ECG)
TimeFrame: Up to day 15
Description: The overall conclusion of the continuous ECG will be recorded as normal or abnormal, with a comment added if abnormal.
Measure: Safety assessed by Real-time cardiac monitoring (telemetry) (Part 1)
TimeFrame: Day 1
Description: Number of participants with potentially clinically significant telemetry abnormalities.

Trial Information

NCT ID

NCT03682484

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Astellas Pharma Global Development, Inc.

Last Updated

December 15, 2025

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