Actively Recruiting
Evaluation of 626 in Healthy Adult Subjects
Led by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Updated on 2024-12-10
50
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
CONDITIONS
Official Title
Evaluation of 626 in Healthy Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand protocol requirements and sign a written informed consent form
- Male or female aged 18 to 45 years at the time of consent
- Male subjects weighing at least 50 kg, female subjects weighing at least 45 kg, with a BMI between 18 and 28 kg/m2
- Normal test results or abnormal results without clinical significance as judged by the investigator
- Female subjects of childbearing potential and male subjects (and their female partners) must agree to use highly effective contraception
You will not qualify if you...
- History of severe allergy or allergy to the study treatment or related excipients
- Presence of any clinically significant diseases before screening
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- History of significant alcohol or drug abuse
- Positive urine nicotine test at screening
- Pregnant or nursing females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
Research Team
Q
Qinghong Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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