Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects
Lead Sponsor:
Shenzhen Turier Biotech Co., Ltd
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 af...
Eligibility Criteria
Inclusion
- Written and signed informed consent.
- Aged 18-55 years (inclusive), male or female.
- BMI within 18.0-28.0 kg/m2 (inclusive).
- Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
- Have agreed to take effective contraception measures.
Exclusion
- Have any prior clinically serious disease of any system.
- Known or suspected allergy to the study drug or any of its ingredients.
- Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
- History of recurrent or chronic infection within 6 months prior to the first administration.
- Unable to comply with dietary management during the study period.
- Pregnant or lactating women.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05308940
Start Date
January 10 2022
End Date
August 23 2022
Last Update
April 13 2023
Active Locations (1)
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1
Shenzhen Turier Biotech Co., Ltd.
Shenzhen, Guangdong, China, 518122