Clinical trial NCT06917742: A Study of CPTX2309 in Healthy Participants
Official title: A First-in-Human, Phase 1, Single-Center, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: Capstan Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 adult participants.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with changes in the safety parameters
timeFrame: 8 weeks
measure: Number of participants with clinical laboratory assessment abnormalities
timeFrame: 8 weeks
measure: Number of participants with changes in the vital signs
timeFrame: 8 weeks
measure: Number of participants with changes in the ECG
timeFrame: 8 weeks
measure: Number of participants who develop anti-drug antibodies (ADAs) to CPTX2309
timeFrame: 8 weeks
measure: Number of participants with change from baseline in vaccine antibody titers
timeFrame: 8 weeks
measure: Changes in serum cytokine and chemokine levels that are known to be associated with CAR-T cell therapy related toxicity
timeFrame: 8 weeks
measure: Change from baseline in soluble immunoglobulins (Ig)
timeFrame: 8 weeks
Secondary outcomes:
measure: Pharmacokinetic Parameters
timeFrame: 8 weeks
measure: Pharmacodynamic Parameters
timeFrame: 8 weeks
measure: Pharmacodynamic Parameters
timeFrame: 8 weeks
measure: Pharmacodynamic Parameters
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Nucleus Network Brisbane
state: Queensland
Study officials:
affiliation: Capstan Therapeutics, Inc.
name: Ramin Farzaneh-Far, MD
role: STUDY_DIRECTOR
References: