A Phase I, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of SN2001 in Healthy Adult Subjects

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• Age 18 to 55 years, inclusive.

• Body mass index (BMI) ≥18.0 kg/m2 and ≤ 32.0 kg/m2.

• Participants are in good general health as determined by the investigator, based on a medical evaluation including medical history, vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests.

• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral ovariectomy or post-menopause. A postmenopausal state should be confirmed by at least 12 months since last menstrual period and FSH \> 40 IU.

• Women of childbearing potential (WOCBP) may be enrolled in the study if the participant:

‣ has practiced highly-effective contraception for 28 days prior to first injection, and

⁃ has a negative pregnancy test at Screening, and

⁃ agrees to refrain from ova donation from Screening until 48 weeks after completion of the final injection, and

⁃ practices abstinence as part of her usual and preferred lifestyle, and

⁃ has agreed to continue highly-effective contraception from Screening until 48 weeks after completion of the final injection.

• Male participants:

‣ with documented bilateral orchiectomy, or

⁃ agrees to practice abstinence from penile-vaginal intercourse or use condoms from Screening until 48 weeks after completion of the final subcutaneous injection, and

⁃ agrees to refrain from sperm donation from Screening until 48 weeks after completion of the final injection, and

⁃ the highly effective contraceptive methods listed above should also apply to WOCBP partners of male participants for the specified duration, in addition to male condom use, from Screening until 48 weeks after completion of the final injection.

• Willing to comply with the study requirements and to provide written informed consent.

Locations
Other Locations
Australia
Q-Pharm Pty Ltd.
RECRUITING
Herston
Contact Information
Primary
Clinical Development VP, PhD
contact@chimigen.com
+1-917-439-9820
Time Frame
Start Date: 2025-08-19
Estimated Completion Date: 2027-04
Participants
Target number of participants: 36
Treatments
Experimental: Cohort A
Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo.
Experimental: Cohort B
Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo.
Experimental: Cohort C
Participants will be randomized in a 3:1 ratio to receive 4 doses of either SN2001 or placebo.
Related Therapeutic Areas
Sponsors
Leads: Chimivac INC

This content was sourced from clinicaltrials.gov

Similar Clinical Trials