A single -ascending dose study of TX000045 in healthy participants

Exclusion Criteria10

• Participants are excluded from the study if any of the following criteria apply:
• Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of significant psychiatric disorders at the discretion of the investigator.
• Has any clinically significant physical examination abnormalities observed during the screening visit or would not be a good candidate for participation in the study in the opinion of the investigator.
• Has clinically significant abnormal complete blood count, clinical chemistry, or urine analysis at screening or Day -1. In asymptomatic participants, any abnormal laboratory results, including creatine phosphokinase within 3 times the upper limit of normal with suspected cause due to rigorous physical activities, may be repeated once during the screening period.
• Was hospitalized for any reason within 30 days of the screening visit.
• Has any history of clinically significant renal, neurologic, gastrointestinal, hepatic, or respiratory disease. Note that subjects with fully resolved childhood asthma with no recurrence in adulthood may be enrolled.
• Has a history of anaphylaxis or other significant allergy in the opinion of the investigator.
• Has a history of clinically significant cardiovascular disease including arrhythmias, conduction abnormalities, or clinically significant abnormal vital signs.
• Was previously administered relaxin or relaxin fusion proteins.
• Was dosed in any clinical research study evaluating another investigational drug (including biologics) or therapy (including specific immunotherapy) within 90 days or less than or equal to 5 half-lives (whichever is longer) of an investigational biologic drug, or less than or equal to 4 weeks for other investigational products, before the screening visit.