Actively Recruiting
A Phase I, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of SN2001 in Healthy Adult Subjects
Led by Chimivac INC · Updated on 2025-08-24
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SN2001, a biological treatment, in healthy adult males aged 18 to 55 years to study its safety, tolerability, and immune response. This randomized, double-blind, placebo-controlled Phase 1 trial involves multiple doses of SN2001 and aims to better understand how the body reacts to this treatment in terms of side effects and immune system activation. Participants will be randomly assigned in a 3:1 ratio to receive four doses of SN2001 or placebo through subcutaneous injections at doses of 100, 200, or 300 micrograms. The study will compare these dose levels in separate experimental groups to assess the effects of SN2001. The dosing schedule and placebo control help ensure a thorough evaluation of the treatment's impact. During the study, participants will be monitored for adverse events, vital signs, physical exams, ECGs, and lab tests up to 48 weeks following the last injection. Immune responses will be measured through antibody levels and specific immune cell activity for up to 24 weeks after the final dose. Participants will undergo regular assessments to track safety and immune parameters, providing detailed information on the treatment's effects over time.
CONDITIONS
Brief Title
A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 55 years, inclusive
- Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
- Good general health as determined by medical evaluation including history, vital signs, physical exam, ECG, and lab tests
- Female participants of non-childbearing potential may be enrolled
- Women of childbearing potential must use effective contraception, have a negative pregnancy test, and agree to abstinence or contraception during study and 48 weeks after
- Male participants must agree to abstinence or condom use during study and 48 weeks after, and their partners must use effective contraception
- Willing to comply with study requirements and provide written informed consent
You will not qualify if you...
- History of Hepatitis B virus (HBV) infection as shown by HBV Surface and Core antigens
- Active infection with HIV, hepatitis C, A, D, syphilis, or other chronic viral infections
- Known exposure to HBV within past 6 weeks
- Previous HBV vaccination or planned vaccination within 48 weeks after study dosing
- Participation in investigational drug or vaccine trials within 3 months or 5 half-lives prior to screening
- Elevated liver enzymes or clinically significant lab abnormalities at screening
- History of significant medical illness including neurological, cardiovascular, hepatic, renal, gastrointestinal, respiratory, metabolic, or skeletal diseases
- History of cancer within 3 years except certain cured skin or cervical conditions
- Conditions impairing immune response such as diabetes
- Severe trauma or major surgery within 3 months or planned during study
- Use of immune-affecting medications within 3 months prior to study
- Use of prescription drugs or vaccines within 14 days before dosing
- Use of OTC medications or herbal supplements within 7 days before dosing except routine vitamins and pain relievers
- Smoking 10 or more cigarettes daily within 3 months before screening or inability to stop tobacco use during study
- History or evidence of alcohol abuse or unwillingness to abstain after dosing
- History or evidence of drug abuse within 12 months before screening
- Positive drug or alcohol tests at screening
- History of severe allergic or injection site reactions
- Blood donation exceeding 400 mL within 30 days before dosing
- Any condition making participation unsuitable in opinion of Investigator or interfering with study completion
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of dosing period (exact time not specified)
Participants receive 4 doses of SN2001 or placebo through subcutaneous injections as part of the randomized dose-ranging study.
4 dosing visits (in-person)
Duration - Up to 48 weeks after the final study injection
Participants are monitored for safety, tolerability and immune response through periodic assessments after the final dose.
Periodic visits for safety and immunogenicity assessments
Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
C
Clinical Development VP, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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