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Monoclonal Antibodies
B1344 Vaccine Safety in Healthy Subjects
Phase 1
Recruiting
Research Sponsored by Tasly Biopharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 days of administration
Summary
This trial tested a vaccine's safety, tolerability, and effectiveness in healthy people by giving single injections under the skin.
Who is the study for?
Healthy adults aged 18-55, both men and women (women must be non-pregnant, non-lactating, and either of non-childbearing potential or using effective contraception), with a BMI of 18.5 to 29.9 kg/m2 can join this trial. Participants should not have significant health issues or be taking other medications that could affect the study.
What is being tested?
The trial is testing B1344's safety when given as a subcutaneous injection compared to a placebo in healthy subjects. It aims to understand how well people tolerate it and what happens inside the body after it's taken.
What are the potential side effects?
While specific side effects are not listed for B1344, common reactions to injections may include pain at the injection site, swelling, redness, itching, rash or bruising; systemic side effects might involve headaches, fatigue or fever.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 3 days of administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 days of administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
12-lead electrocardiogram (ECG)
Anti-Drug Antibody(ADA)
Injection site reactions assessments
+2 moreTrial Design
7Treatment groups
Placebo Group
Group I: Cohort 1Placebo Group2 Interventions
B1344/Placebo:2mg.
Group II: Cohort 2Placebo Group2 Interventions
B1344/Placebo:5mg.
Group III: Cohort 3Placebo Group2 Interventions
B1344/Placebo:15mg.
Group IV: Cohort 4Placebo Group2 Interventions
B1344/Placebo:30mg.
Group V: Cohort 5Placebo Group2 Interventions
B1344/Placebo:45mg.
Group VI: Cohort 6Placebo Group2 Interventions
B1344/Placebo:60mg.
Group VII: Cohort 7Placebo Group2 Interventions
B1344/Placebo:80mg.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Tasly Biopharmaceuticals Co., Ltd.Lead Sponsor
5 Previous Clinical Trials
2,551 Total Patients Enrolled
Kongli Zhu, MDStudy ChairTasly Biopharmaceuticals Co., Ltd.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a family history of a heart condition called long QT syndrome.You have any condition or disease that affects your brain, lungs, heart, digestive system, blood, hormones, bones, or urinary system, or any other condition that could affect your participation in the study or be risky for you according to the doctor's evaluation.You have a bone condition like osteoporosis or have had fractures or significant bone injuries/surgeries.You have taken certain medications for bone health in the past that may affect your eligibility for the study. These medications include oral bisphosphonates for a certain period of time, intravenous bisphosphonates, fluoride, strontium, parathyroid hormone or its derivatives, or denosumab.The principal investigator has determined that you have other medical conditions that make you ineligible for the study.You are allergic to the study drug or any ingredients in it, or you have a history of severe allergies to food or medications.You have a history of gastrointestinal disorders like acid reflux, chronic diarrhea, stomach inflammation, or conditions like Crohn's disease and ulcerative colitis.You have taken certain medications in the past three months, such as hormone replacement therapy or drugs that affect your bones or hormones.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
- Group 5: Cohort 5
- Group 6: Cohort 6
- Group 7: Cohort 7
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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