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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~within 3 days of administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 days of administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-lead electrocardiogram (ECG)
Anti-Drug Antibody(ADA)
Injection site reactions assessments
+2 more

Trial 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.

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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

B1344 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05655221 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: B1344 Highlights & Side Effects. Trial Name: NCT05655221 — Phase 1
B1344 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05655221 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitments for this investigation ongoing?

"Absolutely, according to clinicaltrials.gov's data the research trial is still in progress and recruiting patients as of this moment. This project was first uploaded on August 30th 2022 with its most recent update occurring on December 8th 2022. The investigators aim to enrol 56 volunteers from a single medical site."

Answered by AI

To what extent might this therapy be detrimental to patients?

"Due to the limited clinical evidence available, our team at Power has allocated a score of 1 for this treatment's safety. This suggests that it is an initial Phase 1 trial and further research is necessary in order to determine efficacy and security."

Answered by AI

Who would be a suitable candidate to take part in this medical experiment?

"To be selected for this therapeutic trial, applicants must have a diagnosis of non-alcoholic fatty liver disease and fall within the age range 18 to 55. The clinical team is looking to include around 56 individuals in total."

Answered by AI

How many individuals are receiving treatment in this medical investigation?

"Affirmative. Clinicaltrials.gov's information reveals that this medical study is currently recruiting patients, and it was first posted on August 30th 2022 before being updated a few months later. In total, 56 individuals need to be signed up from 1 centre."

Answered by AI

Is this clinical experiment open to individuals beyond the age of 45?

"The lower age limit for this trial is 18 and the upper boundary of participant's ages must be 55 or under."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects
2022. "A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05655221.
~21 spots leftby May 2025
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