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This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)
This is a first-in-human, randomized, double-blind, placebo-controlled clinical trial in healthy subjects. The trial consists of two parts: Part 1: a single ascending dose (SAD) study with seven dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose groups), with two subjects enrolled in the 2 mg group (all receiving the test drug), and eight subjects enrolled in each of the remaining groups (six test drug and two placebo); Part 2: a multiple ascending dose (MAD) study with seven dose groups: two subjects (six test drug and two placebo); and Part III: a randomized, double-blind, placebo-controlled clinical trial in healthy subjects, with a randomized, double-blind, placebo-controlled clinical trial in healthy subjects. Part II: Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each including 8 healthy subjects (6 test drug, 2 placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | A single ascending dose (SAD) study divided into 7 dose groups: 2 mg (exploratory dose), 24 mg, 50 mg, 100 mg, 200 mg, and 300 mg, 400 mg (optional dose group), with 2 mg enrolling 2 subjects (all receiving the test drug) and the remaining 8 subjects in each group (6 test drug, 2 placebo). |
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| Part 2 | Experimental | Multiple ascending dose (MAD) study, divided into 3 dose groups: 100 mg, 200 mg and 300 mg, each group included 8 healthy subjects (6 test drug, 2 placebo). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG136 | Drug | Subjects injected with BG136 in Part 1 and Part 2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 14 days |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | up to 14 days |
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | up to 14 days |
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao, doctor | Contact | 86-18661809090 | caoyu1767@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Cao, doctor | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Qingdao University Phase I Clinical Research Center | Recruiting | Qingdao | Shandong | 266003 | China |
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Single-dose and multi-dose, dose escalation, placebo-controlled study
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| Placebo |
| Drug |
Subjects injected with Placebo in Part 1 and Part 2 |
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