Actively Recruiting
Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-08-06
30
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.
CONDITIONS
Official Title
Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 55 years; at least 3 participants per gender for each cohort
- Body mass index (BMI) between 18 and 30
- Weight at least 50 kg for males and 45 kg for females
- No clinically significant abnormalities in medical history, physical exam, vital signs, lab tests, ECG, or pulmonary imaging
- Men and women of childbearing potential must use effective contraception throughout the study and have no plans to conceive
- Women of childbearing potential must have a negative pregnancy test and not be breastfeeding
- Women who are not of childbearing potential must be post-hysterectomy, post-salpingectomy, or postmenopausal (FSH >40 IU/L)
- Able and willing to provide informed consent and comply with study requirements
You will not qualify if you...
- Allergy to GenSci120 or history of severe allergies
- Injection site issues affecting evaluation
- Significant medical conditions that could impact study outcomes
- History of malignant tumors, including specific listed cancers
- History of seizures or head injury causing unconsciousness
- Psychiatric disorders impairing daily functioning or cognitive ability
- Severe immunodeficiency such as HIV infection
- Recent trauma, surgery, or gastrointestinal problems affecting absorption
- Recent severe infections or antimicrobial treatments
- Receipt of live vaccines within one month prior to screening
- Abnormal vital signs or ECG, including extreme blood pressure or QTcF >450 ms
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or tuberculosis
- Recent use of immunosuppressive or targeted therapies
- Use of medications within 14 days prior to randomization
- Recent participation in other clinical trials
- Excessive alcohol consumption over the past six months
- Heavy smoking, unwillingness to quit, or positive nicotine tests
- Positive drug screening for specified substances
- Recent use of soft or hard drugs within specified timeframes
- Recent blood donation or receipt of blood products or poor venous access
- Staff involved in the study
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
Y
Yiting Chi, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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