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The main aim of this clinical trial is to assess the safety of FT1 in participants aged 18 to 45 years. The main questions it aims to answer are:
• Is FT1 safe in healthy adults? Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and active in human.
Participants will
This study is a first-in-human study, which is a single-center, randomized, placebo-controlled, double-blind, dose escalation clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FT1 in healthy adult volunteers.
The trial is divided into 2 parts, single-dose part and multiple-dose part. In multiple-dose part, participants will receive once weekly subcutaneous injection of FT1 for 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose FT1 | Experimental | A single dose of FT1 will be administered, subcutaneous injection |
|
| Single-dose FT1 Placebo | Placebo Comparator | A single dose of FT1 Placebo will be administered, subcutaneous injection |
|
| Multiple-dose FT1 | Experimental | FT1 will be administered once weekly for 3 weeks, subcutaneous injection |
|
| Multiple-dose FT1 Placebo | Placebo Comparator | FT1 Placebo will be administered once weekly for 3 weeks, subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT1 | Drug | Six dose levels will be evaluated in single-dose part, and three dose levels in multiple-dose part. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Adverse Events | To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration. | up to 29 days in single-dose part, and up to 43 days in multiple-dose part |
| Measure | Description | Time Frame |
|---|---|---|
| The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t) | Pharmacokinetic parameter | up to 29 days in single-dose part, and up to 43 days in multiple-dose part |
| Maximum plasma concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bishan Hospital of Chongqing | Chongqing | Chongqing Municipality | 402760 | China |
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| Placebo | Drug | Placebo will be administered. |
|
Pharmacokinetic parameter
| up to 29 days in single-dose part, and up to 43 days in multiple-dose part |
| The half-life (t1/2) | Pharmacokinetic parameter | up to 29 days in single-dose part, and up to 43 days in multiple-dose part |
| Anti-drug Antibody | Immunogenicity of FT1 | up to 29 days in single-dose part, and up to 43 days in multiple-dose part |