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The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Injectable SPN01 in Phase I.

NCT06710561 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-12-03

No results posted yet for this study

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 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

Interventions

DRUG

SPN01 for Injection

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.

OTHER

Placebo

After each subject was randomly assigned, a single intravenous injection of 0.9% sodium chloride was administered

DRUG

SPN01 for Injection

Colorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose.

Sponsors & Collaborators

  • Beijing SonoPhotoNano Medical Technology Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2026-04-10
Completion
2026-04-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06710561 on ClinicalTrials.gov