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Active Not Recruiting NCT07075640

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

Conditions: Healthy Participants

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 24
Sponsor: Agios Pharmaceuticals, Inc.

Location: Fortrea Clinical Research Unit Inc. Madison Wisconsin

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.

Eligibility Criteria

Inclusion Criteria * Male or female, of any race, between 18 and 55 years of age, inclusive. 1. Females must be of nonchildbearing potential. 2. Males must agree to use contraception. 3. 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. * Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m2), inclusive. * Body weight between 50 and 100 kg, inclusive. * In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in, and from the physical examination at screening, as assessed by the investigator or designee. * Able to comprehend and willing to sign the informed consent form (ICF) and abide by the study restrictions. Exclusion Criteria * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee. * History of malignancy, with the exception of adequately treated non-melanomatous skin carcinoma. * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee. * History or presence of iron deficiency or iron deficiency anemia and/or currently receiving oral or parenteral iron supplementation as treatment for those conditions or deemed high risk of iron deficiency as determined by the investigator. 1. Males: ferritin \140 or \90 or \100 or \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07075640). StuddyBuddy aggregates publicly available trial information.