To evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TX000045 (single ascending dose) in Healthy Volunteers

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

Participants must meet the following criteria to be enrolled in this study:
•Is a male or a female of non–childbearing potential between the ages of 18 and 55 years.
•Is judged to be in good health based upon medical history, physical examination, vital signs, ECGs, and routine laboratory tests.
•Has a BMI (body mass index) between 18 and 32 kg per meter square at screening.
•Understands the study procedures and agrees to participate in the study by giving written informed consent.

Exclusion Criteria

Exclusion criteria
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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