A Clinical Study of AK115 in Healthy Subjects

NCT05286970 | Completed Phase 1

• 1 other identifier: AK115-101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence and severity classification of adverse events

  Incidence and severity classification of adverse events

  0-12week

Secondary Outcomes (12)

• Pharmacokinetic parameters of AK115 in healthy subjects

  0-12week

• Pharmacokinetic parameters of AK115 in healthy subjects

  0-12week

• Pharmacokinetic parameters of AK115 in healthy subjects

  0-12week

• Pharmacokinetic parameters of AK115 in healthy subjects

  0-12week

• Pharmacokinetic parameters of AK115 in healthy subjects

  0-12week

Study Arms (6)

0.5mg AK115 SC

EXPERIMENTAL

single-dose

Drug: AK115

1mg AK115or placebo SC

EXPERIMENTAL

single-dose

Drug: AK115; Drug: Placebo

3mg AK115or placebo SC

EXPERIMENTAL

single-dose

Drug: AK115; Drug: Placebo

10mg AK115or placebo SC

EXPERIMENTAL

single-dose

Drug: AK115; Drug: Placebo

30mg AK115or placebo SC

EXPERIMENTAL

single-dose

Drug: AK115; Drug: Placebo

60mg AK115or placebo SC

EXPERIMENTAL

single-dose

Drug: AK115; Drug: Placebo

Interventions

AK115 DRUG

Abdominal subcutaneous injection

0.5mg AK115 SC; 10mg AK115or placebo SC; 1mg AK115or placebo SC; 30mg AK115or placebo SC; 3mg AK115or placebo SC; 60mg AK115or placebo SC

Placebo DRUG

Abdominal subcutaneous injection

10mg AK115or placebo SC; 1mg AK115or placebo SC; 30mg AK115or placebo SC; 3mg AK115or placebo SC; 60mg AK115or placebo SC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects fully understand the purpose, content, process and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent before any test procedure;
• Healthy male and female subjects aged 18-55 years (including 18 and 55 years);
• Male weight ≥ 50.0kg, female weight ≥ 45.0kg; Body mass index (BMI) = body weight (kg) / height 2 (M2), in the range of 19.0 \~ 26.0kg/m2 (including the critical value);
• The blood pregnancy test results of female subjects of chidbearing potential during the screening period were negative. During the whole trial period and within 84 days after receiving the inveatigational drug, the subjects and their partners voluntarily take effective contraceptive measures specified in the protocol. Female subjects without childbearing potential need to meet the standards specified in the protocol,
• The subjects can communicate well with the researchers, understand and comply with the requirements of this trial protocol.

You may not qualify if:

• Allergic to AK115 component and any monoclonal antibody, or have a history of allergies of 3 or more kinds food or drugs ;
• There are accompanying diseases , or previous serious and chronic diseases and those who have not been cured;
• The results of physical examination, laboratory examination or ECG examination in the screening period are judged by the researcher to be abnormal and clinically significant;
• Have a history of transplantation of important organs;
• Abnormal liver and kidney functions and blood routine, refer to the protocol
• Hepatitis B surface antigen, hepatitis C antibody, HIV antigen antibody, Treponema pallidum antibody positive;
• History of alcohol abuse or Drug abusers within 12 months before screening or those with positive urine drug screening results during screening;
• Blood donation or massive blood loss (\> 400ml) or Smoking more than 5 cigarettes per day within 3 months before check-in;
• Female subjects are in pregnancy or lactation;
• Use of medications including over-the-counter medication within 14 days before the investigational drug;
• Participated in the clinical trial of any trial drug within 3 months before the investigational drug or still within 5 half lives of other trial drugs (whichever is longer);
• Subjects who received monoclonal antibodies or other biological agents within 3 months before investigational drug;
• Subjects who had received systemic corticosteroids 12 months before screening;
• Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, 650000, China

Location

Related Publications (1)

• 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.

  PMID: 40297315 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 18, 2022
• Study Start: March 18, 2022
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)