A First-in-Human, Phase 1, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers and Subjects With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)

First-in-human study of CPTX2309 for RA and SLE patients begins recruitment

NCT: NCT06917742 · Status: RECRUITING · Phase: Phase 1 · Sponsor: Capstan Therapeutics · Started: 2025-04-09 · Est. Completion: 2027-11

Plain English Summary

A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE) is a Phase 1 clinical trial sponsored by Capstan Therapeutics studying Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus. This study tests the safety and tolerability of a new drug called CPTX2309 given through an IV. It is for healthy adults and adults with moderate to severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE). Participants will receive CPTX2309 intravenously and be monitored for side effects and how the drug works in the body. Currently, there are no approved alternatives for this specific investigational drug, but standard treatments exist for RA and SLE. The trial aims to enroll 64 participants.

Official Summary

The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.

Who Can Participate

Here is what you need to know about eligibility for this trial. Healthy adults aged 18 and over. Adults with moderate to severe Rheumatoid Arthritis (RA) who meet specific disease activity criteria. Adults with moderate to severe Systemic Lupus Erythematosus (SLE) who meet specific diagnostic criteria. Individuals with significant organ dysfunction or other major health issues may not be eligible. This trial is studying Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe CPTX2309 is by tracking changes in vital signs, lab tests, and the body's immune response to the drug, ensuring it doesn't cause harmful effects. The specific primary outcome measures are: Number of participants with changes in the safety parameters (Up to approximately 1 Year); Number of participants with clinical laboratory assessment abnormalities (Up to approximately 1 Year); Number of participants with changes in the vital signs (Up to approximately 1 Year); Number of participants with changes in the ECG (Up to approximately 1 Year); Number of participants who develop anti-drug antibodies (ADAs) and Circulating Immune Complex (CIC) formation (Up to approximately 1 Year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it explores a new potential treatment for debilitating autoimmune diseases like RA and SLE, addressing an unmet need for novel therapies. This research targets Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus, where improved treatment options are needed.

Investor Insight

This Phase 1 trial is a crucial early step for CPTX2309, indicating the sponsor's commitment to developing a new therapy for autoimmune diseases, a significant market with ongoing innovation. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if CPTX2309 is a suitable option for you and what potential risks are involved. Participation involves regular clinic visits for IV infusions and monitoring of your health and response to the drug. You will need to follow a strict schedule for visits and may need to avoid other investigational treatments during the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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.

RA Only:

* Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA
* Presence of rheumatoid factor or ACPA above the ULN
* Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)/66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment.

SLE Only:

* Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria for SLE
* Positive ANA\>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).

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.

RA Only:

\- Participants diagnosed with Felty's syndrome

SLE Only:

* Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible)
* Note: Other protocol-defined inclusion/exclusion criteria apply

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06917742?

NCT06917742 is a Phase 1 INTERVENTIONAL study titled "A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)." It is currently recruiting and is sponsored by Capstan Therapeutics. The trial targets enrollment of 64 participants.

What conditions does NCT06917742 study?

This trial investigates treatments for Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus. The primary condition under study is Healthy Volunteers.

What treatments are being tested in NCT06917742?

The interventions being studied include: CPTX2309 (DRUG), CPTX2309 (DRUG). Intravenous Infusion

What does Phase 1 mean for NCT06917742?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT06917742?

This trial is currently "Recruiting." It started on 2025-04-09. The estimated completion date is 2027-11.

Who is sponsoring NCT06917742?

NCT06917742 is sponsored by Capstan Therapeutics. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06917742?

The trial aims to enroll 64 participants. The trial is currently recruiting and accepting new participants.

How is NCT06917742 designed?

This is a interventional study, uses non_randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT06917742?

The primary outcome measures are: Number of participants with changes in the safety parameters (Up to approximately 1 Year); Number of participants with clinical laboratory assessment abnormalities (Up to approximately 1 Year); Number of participants with changes in the vital signs (Up to approximately 1 Year); Number of participants with changes in the ECG (Up to approximately 1 Year); Number of participants who develop anti-drug antibodies (ADAs) and Circulating Immune Complex (CIC) formation (Up to approximately 1 Year). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06917742 being conducted?

This trial is being conducted at 1 site, including Herston, Queensland (Australia).

Where can I find official information about NCT06917742?

The official record for NCT06917742 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06917742. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06917742 testing in simple terms?

This study tests the safety and tolerability of a new drug called CPTX2309 given through an IV. It is for healthy adults and adults with moderate to severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE).

Why is this trial significant?

This trial is important because it explores a new potential treatment for debilitating autoimmune diseases like RA and SLE, addressing an unmet need for novel therapies.

What are the potential risks of participating in NCT06917742?

The most common risks are related to the IV infusion itself, such as pain or redness at the injection site. Potential side effects could include changes in lab test results, vital signs, or the development of antibodies against the drug. For RA patients, specific conditions like Felty's syndrome are excluded. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06917742?

Ask your doctor if CPTX2309 is a suitable option for you and what potential risks are involved. Participation involves regular clinic visits for IV infusions and monitoring of your health and response to the drug. You will need to follow a strict schedule for visits and may need to avoid other investigational treatments during the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06917742 signal from an investment perspective?

This Phase 1 trial is a crucial early step for CPTX2309, indicating the sponsor's commitment to developing a new therapy for autoimmune diseases, a significant market with ongoing innovation. This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will receive CPTX2309 intravenously and be monitored for side effects and how the drug works in the body. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.