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This trial is a randomized, double-blind, placebo-controlled dose escalation phase I trial following single dose subcutaneous administration of AK115 injection.
It aims to evaluate the safety, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single dose of AK115 injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5mg AK115 SC | Experimental | single-dose |
|
| 1mg AK115or placebo SC | Experimental | single-dose |
|
| 3mg AK115or placebo SC | Experimental | single-dose |
|
| 10mg AK115or placebo SC | Experimental | single-dose |
|
| 30mg AK115or placebo SC | Experimental | single-dose |
|
| 60mg AK115or placebo SC | Experimental | single-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK115 | Drug | Abdominal subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity classification of adverse events | Incidence and severity classification of adverse events | 0-12week |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of AK115 in healthy subjects | Pharmacokinetic parameters of AK115 in healthy subjects: peak concentration (Cmax) | 0-12week |
| Pharmacokinetic parameters of AK115 in healthy subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunnan Provincial Hospital of Traditional Chinese Medicine | Kunming | Yunnan | 650000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40297315 | Derived | Zhang J, Fan YX, Huang Y, Guan R, Li R, Long S, Yang M, Yu B, Wang GQ, Chen P, Gong X, Li B, Xia M, He J. The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administration of a Novel Anti-NGF Monoclonal Antibody (AK115) in Healthy Participants: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial. Drug Des Devel Ther. 2025 Apr 24;19:3225-3235. doi: 10.2147/DDDT.S500902. eCollection 2025. |
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| Placebo | Drug | Abdominal subcutaneous injection |
|
Pharmacokinetic parameters of AK115 in healthy subjects: time to peak (Tmax)
| 0-12week |
| Pharmacokinetic parameters of AK115 in healthy subjects | Pharmacokinetic parameters of AK115 in healthy subjects: apparent terminal elimination rate constant( λ z) | 0-12week |
| Pharmacokinetic parameters of AK115 in healthy subjects | Pharmacokinetic parameters of AK115 in healthy subjects: Area under drug time curve (AUC) | 0-12week |
| Pharmacokinetic parameters of AK115 in healthy subjects | Pharmacokinetic parameters of AK115 in healthy subjects: apparent total body clearance (CL / F) | 0-12week |
| Pharmacokinetic parameters of AK115 in healthy subjects | Pharmacokinetic parameters of AK115 in healthy subjects: apparent distribution volume (VZ / F) | 0-12week |
| Pharmacokinetic parameters of AK115 in healthy subjects | Pharmacokinetic parameters of AK115 in healthy subjects: elimination half-life (T1 / 2) | 0-12week |
| Pharmacokinetic parameters of AK115 in healthy subjects | Pharmacokinetic parameters of AK115 in healthy subjects: mean residence time (MRT), etc | 0-12week |
| Changes in serum total nerve growth factor (NGF) levels from baseline. | Changes in serum total nerve growth factor (NGF) levels from baseline. | 0-12 week |
| Immunogenicity characteristics: the number and percentage of anti AK115 antibody (ADA) | Immunogenicity characteristics: the number and percentage of anti AK115 antibody (ADA) | 0-12week |
| Immunogenicity characteristics: the number and percentage of neutralizing antibody (NAB) positive subjects | Immunogenicity characteristics: the number and percentage of neutralizing antibody (NAB) positive subjects | 0-12week |
| Immunogenicity characteristics: time to ADA positive | Immunogenicity characteristics: time to ADA positive | 0-12week |