Status:

RECRUITING

A Study of CPTX2309 in Healthy Participants

Lead Sponsor:

Capstan Therapeutics

Conditions:

Healthy Volunteers

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants.

Detailed 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 adul...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 9 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT06917742

Start Date

April 9 2025

End Date

February 1 2026

Last Update

May 28 2025

Active Locations (1)

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1

Nucleus Network Brisbane

Herston, Queensland, Australia, 4006