A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects
Study Details
Study Description
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 after single and multiple subcutaneous injections in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single-dose of TB001 In the SAD stage, participants will receive subcutaneous injection of TB001 once on Day 1, planning to ascend from 20 μg, 60 μg，150 μg，300 μg，600μg to 900 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. |
Drug: TB001
once-daily subcutaneous injection, on Day 1 in SAD stage
|
| Experimental: Multiple-dose of TB001 In the MAD stage, participants will receive subcutaneous injection of TB001 once daily for 7 days, planning to ascend from 60 μg，150ug to 300 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts. |
Drug: TB001
once-daily subcutaneous injection, on Days 1-7 in MAD stage
|
| Placebo Comparator: Single-dose of placebo In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1. |
Drug: Placebo
once-daily subcutaneous injection, on Day 1 in SAD stage
|
| Placebo Comparator: Multiple-dose of placebo In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days. |
Drug: Placebo
once-daily subcutaneous injection, on Days 1-7 in MAD stage
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events (AEs) [Day 1 and up to Day 28]
An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.
Secondary Outcome Measures
- Pharmacokinetics exposure of TB001 in SAD and MAD stage [Day 1 , Day 7]
Serum concentrations of TB001 at different timepoints before and after TB001 administration.
- Observed immunogenicity of TB001 in MAD stage [Day 1, Day 7, Day 14, Day 28]
Number of subjects who develop detectable ADAs and NAb after TB001 administration.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written and signed informed consent.
-
Aged 18-55 years (inclusive), male or female.
-
BMI within 18.0-28.0 kg/m2 (inclusive).
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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 Criteria:
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Have any prior clinically serious disease of any system.
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Known or suspected allergy to the study drug or any of its ingredients.
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Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
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History of recurrent or chronic infection within 6 months prior to the first administration.
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Unable to comply with dietary management during the study period.
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Pregnant or lactating women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shenzhen Turier Biotech Co., Ltd. | Shenzhen | Guangdong | China | 518122 |
Sponsors and Collaborators
- Shenzhen Turier Biotech Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TB001CT0001