Active — Not RecruitingPhase 1

A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants

United States24 participantsStarted 2025-07-07

Plain-language summary

The primary purpose of this study is to assess the safety and tolerability of a single dose of AG-236 administered subcutaneously in healthy participants.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Females must be of nonchildbearing potential.
✓. Males must agree to use contraception.
✓. Males must agree not to donate sperm during the study and for 90 days or 5-half-lives of AG-236 in plasma, whichever is longer, after dose administration.

Exclusion criteria

✕. Males: ferritin \<30 nanogram per millilitres (ng/mL) and/or transferrin saturation (TSAT): ≤25%.
✕. Females: ferritin \<30 ng/mL and/or TSAT: ≤20%.
✕. QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 milliseconds (ms) in males or \>470 ms in females, confirmed by calculating the mean of the triplicate values obtained
✕. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome).
✕. Clinical laboratory values that are outside the normal reference range and are considered clinically significant, as determined by the investigator.
✕. Clinical laboratory values for hemoglobin (Hb) for males \<13.8 grams per decilitres g/dL and females \<12.1 g/dL.
✕. Clinical laboratory values for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or total bilirubin \>1 × upper limit of normal (ULN).

What they're measuring

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug

Timeframe: Up to Day 57

Trial details

NCT IDNCT07075640

SponsorAgios Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-11

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