A Trial to Evaluate the Safety Tolerability and Pharmacokinetics of B1344 by Subcutaneous Injection in Healthy Subjects

Phase 1

Recruiting

• Conditions: Nonalcoholic Steatohepatitis
• Interventions: Drug: B1344; Other: Placebo

• Registration Number: NCT05655221
• Lead Sponsor: Tasly Biopharmaceuticals Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-30
• Study First Submitted: 2022-11-11
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19
• Primary Completion: 2023-07-31
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 5	B1344	B1344/Placebo:45mg.
Cohort 5	Placebo	B1344/Placebo:45mg.
Cohort 6	B1344	B1344/Placebo:60mg.
Cohort 6	Placebo	B1344/Placebo:60mg.
Cohort 1	B1344	B1344/Placebo:2mg.
Cohort 1	Placebo	B1344/Placebo:2mg.
Cohort 2	B1344	B1344/Placebo:5mg.
Cohort 2	Placebo	B1344/Placebo:5mg.
Cohort 3	B1344	B1344/Placebo:15mg.
Cohort 3	Placebo	B1344/Placebo:15mg.
Cohort 4	B1344	B1344/Placebo:30mg.
Cohort 4	Placebo	B1344/Placebo:30mg.
Cohort 7	Placebo	B1344/Placebo:80mg.
Cohort 7	B1344	B1344/Placebo:80mg.

Primary Outcome Measures

Name	Time	Method
12-lead electrocardiogram (ECG)	From the screening period to 29 days after administration	Changes of 12-lead ECG from baseline
Physical examinations	From the screening period to 90 days after administration	Number of participants with abnormal Physical examinations.
Injection site reactions assessments	Within 3 days of administration	The injection site reaction assessment will be done by the PI/investigational staff and study subject using the criteria, which consist of rating the severity of redness, swelling, skin temperature, sensitivity and pain at the injection site.
Renal Ultrasonography	From the screening period to 29 days after administration	The examination of both kidneys using medical ultrasonography will be performed to detect any harmful abscesses, fluid collection, and infection within or around the kidneys.
Anti-Drug Antibody(ADA)	Within 29 days of administration	he incidence and proportion of ADA positive subjects.

Trial Locations

Locations (1)

California Clinical Trials Medical Group, Inc.; 🇺🇸 Glendale, California, United States