A Study of CPTX2309 in Healthy Participants

Capstan Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CPTX2309

Study type: Interventional

Funder types: Industry

Identifiers

NCT06917742

CPTX2309-01-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

SAD Cohorts

Experimental group

Description:

Escalating single doses of CPTX2309 on a specified day

Treatment:

Drug: CPTX2309

Drug: CPTX2309

MAD Cohorts

Experimental group

Description:

Escalating multiple doses of CPTX2309 on specified days

Treatment:

Drug: CPTX2309

Drug: CPTX2309