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Tests treatment safety and results for Healthy Volunteers
Official title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07476586
What this study is testing
What is GenSci161?
GenSci161 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Healthy adult male or female participants, aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF).
- Male body weight ≥ 50 kg and female body weight ≥ 45 kg at screening; body mass index (BMI) between 18 and 28 kg/m² (inclusive).
- In good general condition as determined by medical history, screening period assessments, such as physical examination, vital signs, ECG, laboratory...
- Male and female participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last...
- Participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled...
You likely can't join if
- History of hypersensitivity to GenSci161, any of its excipients, or similar compounds; or a history of allergic diathesis; or a history of allergic...
- Severe trauma or major surgical procedure (e.g., coronary artery bypass grafting, organ resection, gynecological surgery) within 12 months prior to...
- Presence of significant active systemic or local infection (including, but not limited to, bacterial, viral, fungal, or parasitic [helminth]...
- Intolerance to abdominal subcutaneous injection, or the presence of tattoos, sunburn, scars, or any other factors at the intended injection site that...
- History or current presence of any clinically significant, poorly controlled chronic disease or organ dysfunction that, in the investigator's...
- A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle...
See the full eligibility criteria
- Healthy adult male or female participants, aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF).
- Male body weight ≥ 50 kg and female body weight ≥ 45 kg at screening; body mass index (BMI) between 18 and 28 kg/m² (inclusive).
- In good general condition as determined by medical history, screening period assessments, such as physical examination, vital signs, ECG, laboratory tests, and imaging examinations, with all results within reference...
- Male and female participants of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose. From the time of signing the ICF until 6 months after the last...
- Participants must voluntarily sign the ICF, be able to understand and comply with the requirements of this trial protocol, and complete scheduled follow-up visits in a timely manner.
- History of hypersensitivity to GenSci161, any of its excipients, or similar compounds; or a history of allergic diathesis; or a history of allergic diseases.
- Severe trauma or major surgical procedure (e.g., coronary artery bypass grafting, organ resection, gynecological surgery) within 12 months prior to screening, or planning to undergo any surgery (including cosmetic...
- Presence of significant active systemic or local infection (including, but not limited to, bacterial, viral, fungal, or parasitic [helminth] infections) at any time from 4 weeks prior to screening until the day of...
- Intolerance to abdominal subcutaneous injection, or the presence of tattoos, sunburn, scars, or any other factors at the intended injection site that may interfere with site assessment.
- History or current presence of any clinically significant, poorly controlled chronic disease or organ dysfunction that, in the investigator's judgment, could compromise the trial's conduct. This includes, but is not...
- A positive result at screening for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum particle agglutination assay (TPPA), or hepatitis B virus (HBV) infection...
- Administration of any live or live-attenuated vaccine within 12 weeks prior to screening or planning to receive any live or live-attenuated vaccine (with the exception of inactivated influenza vaccine) during the trial...
- Any other condition that, in the judgment of the investigator, would make the participant unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.