B1344 Vaccine Safety in Healthy Subjects

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Tasly Biopharmaceuticals Co., Ltd.

Trial Summary

What is the purpose of this trial?

To evaluate the safety, tolerability, and immunogenicity of B1344 by single subcutaneous (s.c.) injection in healthy subjects

Research Team

Kongli Zhu, MD

Principal Investigator

Tasly Biopharmaceuticals Co., Ltd.

Eligibility Criteria

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.

Inclusion Criteria

Understanding and be willing to comply with the study process and requirements

Willing to participate in the study and sign informed consent form (ICF)

Aged 18 to 55 years (inclusive) at the screening visit, male or female

See 4 more

Exclusion Criteria

Subjects infected with syphilis confirmed by Treponema pallidum test

You have a family history of a heart condition called long QT syndrome.

History of drug abuse, or positive urine drug test (e.g., barbiturates, benzodiazepines, methadone, buprenorphine, amphetamines, methamphetamines, opiates, cocaine, cannabinoids) at the screening visit or D-1

See 25 more

Treatment Details

Interventions

B1344 (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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