Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.
Recruiting · NCT07040930 · Interventional (participants receive a specific treatment) · Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
GenSci120Placebo
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Ages 18-55; ≥3 per gender for each cohort.
- BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
- No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
- Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH \>40 IU/L).
- Able to provide informed consent; willing to comply with all study requirements
Exclusion criteria
- Allergy to GenSci120 or severe allergies.
- Injection site issues affecting evaluation.
- Significant medical conditions impacting study outcome.
- History of malignant tumors, including listed cancers.
- Seizure history, head injury causing unconsciousness.
- Psychiatric disorders impairing daily activities or cognitive issues.
- Severe immunodeficiency (e.g., HIV).
- Recent trauma, surgery, or GI issues affecting absorption.
- Recent severe infections or antimicrobial treatments.
- Live vaccines within a month prior to screening.
- Abnormal vital signs/ECG: BP extremes, QTcF \>450ms.
- Positive for hepatitis B/C, HIV, syphilis during screening.
- Positive TB test via IGRA.
- Recent use of immunosuppressive or targeted therapies.
- Medication use within 14 days prior to randomization.
- Participation in other clinical trials recently/currently.
- Excessive alcohol consumption (over six months).
- Heavy smoking, unwillingness to quit, positive nicotine tests.
- Positive drug screen for specific substances.
- Recent soft/hard drug use within specified periods.
- Blood donation/product receipt recently or poor venous access.
- Study staff involved in the trial.
- Other conditions deemed unsuitable by investigators.
Where it is running
1 location listed.
- Huashan Hospital Affiliated to Fudan University - Shanghai, Shanghai Municipality, China