Overview
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants.
Description
A first-in-human Phase 1, open label study to evaluate safety and tolerability of a single ascending dose (SAD) and multiple ascending dose (MAD) of CPTX2309 intravenously administered to healthy adult participants.
Eligibility
Inclusion Criteria:
- Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period.
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
- Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309.
- Note: Other protocol-defined inclusion/exclusion criteria apply