NCT07334249
Not yet recruiting
Phase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of SP-101 Injection Following Single and Multiple Intravenous Doses in Healthy Adult Subjects
Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.1 site in 1 country80 target enrollmentStarted: December 23, 2025Last updated:
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Treatment Emergent Adverse Events, throughout study completion
Overview
Brief Summary
The goal of this First-In-Human (FIH) trial is to learn about safety, tolerability and pharmacokinetics of single and multiple ascending doses of SP-101 in healthy adult volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Willing and able to sign written informed consent;
- •Aged 18 to 45 years old (inclusive), healthy males or females (male-to-female ratio is 1:1);
- •Efficient contraceptive mean required by the protocol, and no plans for fertility, sperm donation or egg donation until 3 months after the last intravenous infusion;
- •Body weight:≥50 kg (Male),≥45 kg (Female), Body Mass Index (BMI) of 18 to 28 kg/m2;
- •Normal laboratory tests results, physical examination, medical history and surgical history review, 12-lead Electrocardiogram recording, and with no evidence of active and chronic diseases;
- •willing and able to comply with all study procedures, restrictions, and visit schedules and to communicate effectively with the investigator;
Exclusion Criteria
- •Individuals with special dietary requirements who cannot adhere to a unified diet (e.g., intolerance to standard meal foods, or those with dysphagia);
- •History of intolerance to IV infusion (e.g., severe pain) or unsuitable venous access (e.g., sclerotic, atrophic veins), difficulties with or contraindications to blood sampling; or a history of needle- or blood-injury-related phobia or syncope;
- •Lactation or a positive pregnancy test at screening or baseline;
- •Any febrile illness or active infection within 14 days prior to the first dose;
- •Evidence of drug / substance abuse within the past 5 years, and/or habitual use of any drugs/substances, or a positive urine drug test at screening or baseline;
- •Abnormal renal function (eGFR \< 90 mL/min/1.73 m²);
- •History of QTc prolongation or demonstration of a clinically relevant ECG abnormality at screening;
- •Excessive consumption of nicotine products within 3 months prior to screening (average daily cigarette consumption \>5 cigarettes), or inability to stop using any tobacco products during the trial, or a positive nicotine test;
- •Previous participation in this study; treatment with an investigational product within 30 days prior to study initiation; or planning participation in another clinical trial during the study period;
- •Positive test result at screening for any of the following: hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV), antibody to human immunodeficiency virus (anti-HIV), or treponemal antibody for syphilis;
Arms & Interventions
Investigational Drug group, SP-101 injection
Experimental
Participants will be randomly assigned to the experimental group and placebo groups at ratio of 3:1. Participants assigned to the experimental group will be administered SP-101 by intravenous infusion. Accordingly, participants assigned to the placebo group will be administered placebo by intravenous infusion.
Intervention: SP-101 injection (Drug)
Placebo group
Placebo Comparator
Participants will be randomly assigned to the experimental group and placebo groups at ratio of 3:1. Participants assigned to the experimental group will be administered SP-101 by intravenous infusion. Accordingly, participants assigned to the placebo group will be administered placebo by intravenous infusion.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Treatment Emergent Adverse Events, throughout study completion
Time Frame: Through study completion, an average of 10 days for SAD and an average of 28 days for MAD
Secondary Outcomes
- Pharmacokinetic Parameter-AUC₀-inf(From 0 hour before dosing to 72 hours after dosing)
- Pharmacokinetic Parameter-AUC₀-last(From 0 hour before dosing to 72 hours after dosing)
- Pharmacokinetic Parameter-Cmax(From 0 hour before dosing to 72 hours after dosing)
- Pharmacokinetic Parameter-Tmax(From 0 hour before dosing to 72 hours after dosing)
- Pharmacokinetic Parameter-T½(From 0 hour before dosing to 72 hours after dosing)
- Pharmacokinetic Parameter-CL(From 0 hour before dosing to 72 hours after dosing)
- Pharmacokinetic Parameter- Vz(From 0 hour before dosing to 72 hours after dosing)
Investigators
Study Sites (1)
Loading locations...
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