Colorectal CarcinomaPhase 1NCT06710561
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01 in Phase I.
A Phase 1 study testing SPN01 for Injection in people with Colorectal Carcinoma, run by Beijing SonoPhotoNano Medical Technology Co., Ltd..
Trial summary
The primary objective of this study is: to evaluate the safety and tolerability of injectable SPN01 in subjects. The secondary objective of this study is: to evaluate the pharmacokinetic characteristics of injectable SPN01 in subjects.The exploratory objectives of this study are: (1)to evaluate the preliminary… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- SPN01 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2024to 10 Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI): BMI between 19.0 kg/m² and 26.0 kg/m² (inclusive). For male subjects, body weight must be ≥50.0 kg; for female subjects, body weight must be ≥45.0 kg.
- Contraceptive Use: Males or females of childbearing potential must use effective contraception during the study and for 30 days after administration. Effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/devices, abstinence, or vasectomy.
- Informed Consent: The subject must fully understand the purpose, nature, methods, and potential adverse effects of the study, voluntarily agree to participate, sign a written informed consent form, and comply with the study protocol.
- For healthy subjects-Age between 18 and 45 years (inclusive), either male or female.
- For healthy subjects-eGFR ≥ 90 ml/min/1.73 m².
- For healthy subjects-Screening phase laboratory results (blood count, blood biochemistry, urine routine, coagulation function) must be normal or clinically insignificant.
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- For healthy subjects-Good general health with no major diseases, as determined by the investigator through history, vital signs, physical examination, clinical ECG, and laboratory test results.
- For colorectal cancer subjects-Age between 18 and 75 years (inclusive), either male or female.
- For colorectal cancer subjects-Pathologically confirmed diagnosis of colorectal cancer and scheduled for surgery (laparoscopic or open surgery).
- For colorectal cancer subjects-No prior targeted treatment for colorectal cancer (including radiotherapy, chemotherapy, targeted therapy, etc.).
- For colorectal cancer subjects-At least one evaluable lesion.
Who cannot join
- Pregnancy or Lactation: Female subjects who are pregnant (positive pregnancy test at screening) or breastfeeding.
- Pregnancy or Donation Plans: Subjects planning to become pregnant or donate sperm/eggs during the study or within 3 months after administration.
- Allergy to SPN01: Known allergy to any component of the investigational drug SPN01, or a history of severe allergies.
- History of Severe Systemic Diseases: A history of serious systemic diseases (including cardiovascular, digestive, urinary, respiratory, endocrine, immune, hematological, lymphatic, musculoskeletal, neurological diseases), liver or kidney dysfunction, or psychiatric disorders.
- Alcohol or Drug Abuse: A history of alcohol or drug abuse/dependence.
- Severe or Uncontrolled Psychiatric Disorder: Subjects with severe or uncontrolled psychiatric diseases.
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- Active Infection: Any active infection requiring systemic treatment or uncontrolled infection within 14 days prior to the start of the study drug.
- Infectious Disease Positive: Subjects who test positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or syphilis; subjects who test positive for hepatitis B virus (HBV) surface antigen.
- Needle Phobia: Subjects with a history of vasovagal response to blood draws or injections and those who cannot tolerate intravenous cannulation.
- Blood Donation or Blood Loss: Subjects who have donated blood or experienced total blood loss of ≥400 mL within the last 3 months.
- Medication Use: Subjects who have taken any prescription drugs, over-the-counter medications, or herbal products within 2 weeks prior to the first dose, especially those who have used antacids (e.g., proton pump inhibitors, H2 receptor antagonists), P-glycoprotein (P-gp) inhibitors, or drugs associated with a risk of torsades de pointes, or those who have used any medications within 30 days prior to the first dose that inhibit or induce liver drug metabolism.
- Other Clinical Trials: Participation in another clinical trial and use of other investigational drugs within 30 days prior to screening.
- Vaccination: Receipt of any vaccination within 3 months prior to screening or plans to receive a vaccine during the study.
- Other Conditions: Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Phase I Single-center, Single-blind, Randomized Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01
The primary objective of this study is: to evaluate the safety and tolerability of injectable SPN01 in subjects. The secondary objective of this study is: to evaluate the pharmacokinetic characteristics of injectable SPN01 in subjects.The exploratory objectives of this study are: (1)to evaluate the preliminary efficacy of injectable SPN01 in subjects with colorectal cancer. (2) to evaluate the effect of the blood concentration of injectable SPN01 on the QTc interval. (3) to evaluate the metabolic characteristics of injectable SPN01 in humans.
- Conditions
- Colorectal Carcinoma
- Being tested
- SPN01 for Injection, Placebo
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPN01 for InjectionDrug
After each subject was randomly assigned, different doses of SPN01 for Injection (0.02 mg/kg, 0.06 mg/kg, 0.12 mg/kg) were administered intravenously in a single dose.
PlaceboOther
After each subject was randomly assigned, a single intravenous injection of 0.9% sodium chloride was administered
SPN01 for InjectionDrug
Colorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Healthy subjects will receive intravenous injection of different doses of injectable SPN01 and placebo in a single dose. Receives: Drug: SPN01 for Injection; Other: Placebo |
| Phase 2 | Experimental | Colorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose. Receives: Drug: SPN01 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Safety and tolerability will be assessed through the monitoring of adverse events (AEs), clinical laboratory tests (including complete blood count, blood biochemistry, coagulation function, and urinalysis), local safety assessments, vital sign checks (including temperature, respiration rate, pulse rate, and blood pressure), 12-lead electrocardiogram (ECG), and physical examinations.
Adverse events (AEs) and serious adverse events (SAEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
All adverse events occurring during the clinical trial will be recorded, including their clinical manifestations, severity, onset and resolution times, management measures, and outcomes. The correlation between AEs and the investigational drug will also be determined.
Measured: Predose and up to 24 hours postdose
Secondary outcomes (10)
Pharmacokinetic - Primary Parameters
Cmax
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Primary Parameters
AUC(0-t)
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Primary Parameters
AUC(0-∞)
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Tmax
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
AUC_%Extrap
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
CL
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Vd
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
MRT
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
λz
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
T1/2
Measured: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start17 Dec 2024 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing SonoPhotoNano Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710561
- Sponsor's protocol ID
- SPN01-Ⅰ-01
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase I Single-center, Single-blind, Randomized Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01
- ClinicalTrials.gov ID
- NCT06710561
- Acronym / sponsor ID
- SPN01-Ⅰ-01
- Conditions
- Colorectal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Beijing SonoPhotoNano Medical Technology Co., Ltd.University, hospital or other
- Study start
- 17 Dec 2024 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is: to evaluate the safety and tolerability of injectable SPN01 in subjects. The secondary objective of this study is: to evaluate the pharmacokinetic characteristics of injectable SPN01 in subjects.The exploratory objectives of this study are: (1)to evaluate the preliminary efficacy of injectable SPN01 in subjects with colorectal cancer. (2) to evaluate the effect of the blood concentration of injectable SPN01 on the QTc interval. (3) to evaluate the metabolic characteristics of injectable SPN01 in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Drug: SPN01 for Injection, Other: PlaceboHealthy subjects will receive intravenous injection of different doses of injectable SPN01 and placebo in a single dose. |
| Phase 2 | Experimental | Drug: SPN01 for InjectionColorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Body Mass Index (BMI): BMI between 19.0 kg/m² and 26.0 kg/m² (inclusive). For male subjects, body weight must be ≥50.0 kg; for female subjects, body weight must be ≥45.0 kg.
- Contraceptive Use: Males or females of childbearing potential must use effective contraception during the study and for 30 days after administration. Effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/devices, abstinence, or vasectomy.
- Informed Consent: The subject must fully understand the purpose, nature, methods, and potential adverse effects of the study, voluntarily agree to participate, sign a written informed consent form, and comply with the study protocol.
- For healthy subjects-Age between 18 and 45 years (inclusive), either male or female.
- For healthy subjects-eGFR ≥ 90 ml/min/1.73 m².
Key exclusion criteria (14 listed)
- Pregnancy or Lactation: Female subjects who are pregnant (positive pregnancy test at screening) or breastfeeding.
- Pregnancy or Donation Plans: Subjects planning to become pregnant or donate sperm/eggs during the study or within 3 months after administration.
- Allergy to SPN01: Known allergy to any component of the investigational drug SPN01, or a history of severe allergies.
- History of Severe Systemic Diseases: A history of serious systemic diseases (including cardiovascular, digestive, urinary, respiratory, endocrine, immune, hematological, lymphatic, musculoskeletal, neurological diseases), liver or kidney dysfunction, or psychiatric disorders.
- Alcohol or Drug Abuse: A history of alcohol or drug abuse/dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPN01 for InjectionAfter each subject was randomly assigned, different doses of SPN01 for Injection (0.02 mg/kg, 0.06 mg/kg, 0.12 mg/kg) were administered intravenously in a single dose. | Drug | Phase 1 |
| PlaceboAfter each subject was randomly assigned, a single intravenous injection of 0.9% sodium chloride was administered | Other | Phase 1 |
| SPN01 for InjectionColorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose. | Drug | Phase 2 |
Primary outcome
Safety and Tolerability
Time frame: Predose and up to 24 hours postdose
Safety and tolerability will be assessed through the monitoring of adverse events (AEs), clinical laboratory tests (including complete blood count, blood biochemistry, coagulation function, and urinalysis), local safety assessments, vital sign checks (including temperature, respiration rate, pulse rate, and blood pressure), 12-lead electrocardiogram (ECG), and physical examinations. Adverse events (AEs) and serious adverse events (SAEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. All adverse events occurring during the clinical trial will be recorded, including their clinical manifestations, severity, onset and resolution times, management measures, and outcomes. The correlation between AEs and the investigational drug will also be determined.
10 secondary outcomes
Pharmacokinetic - Primary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Primary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Primary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Pharmacokinetic - Secondary Parameters
Time frame: For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPN01 for Injection in people with Colorectal Carcinoma, run by Beijing SonoPhotoNano Medical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu (010-84059200, liurenfa@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Predose and up to 24 hours postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.