A Phase I Clinical Trial of AK115 in Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single Dose Subcutaneous Administration of AK115 in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05286970
• Other study ID #: AK115-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 2022
• Est. completion date: March 2023

Study information

• Verified date: March 2022
• Source: Akeso
• Contact: Guoqin Wang, MD
• Phone: +86(0760)89873999
• Email: global.trials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 1) 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;

2) Healthy male and female subjects aged 18-55 years (including 18 and 55 years);

3) 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);

4) 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,

5) The subjects can communicate well with the researchers, understand and comply with the requirements of this trial protocol.

Exclusion Criteria:

1. Allergic to ak115 component and any monoclonal antibody, or have a history of allergies of 3 or more kinds food or drugs ;

2. There are accompanying diseases , or previous serious and chronic diseases and those who have not been cured;

3. 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;

4. Have a history of transplantation of important organs;

5. Abnormal liver and kidney functions and blood routine, refer to the protocol

6. Hepatitis B surface antigen, hepatitis C antibody, HIV antigen antibody, Treponema pallidum antibody positive;

7. History of alcohol abuse or Drug abusers within 12 months before screening or those with positive urine drug screening results during screening;

8. Blood donation or massive blood loss (> 400ml) or Smoking more than 5 cigarettes per day within 3 months before check-in;

9. Female subjects are in pregnancy or lactation;

10. Use of medications including over-the-counter medication within 14 days before the investigational drug;

11. 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);

12. Subjects who received monoclonal antibodies or other biological agents within 3 months before investigational drug;

13. Subjects who had received systemic corticosteroids 12 months before screening;

14. Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AK115
Abdominal subcutaneous injection
• Placebo
Abdominal subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity classification of adverse events	Incidence and severity classification of adverse events	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: peak concentration (Cmax)	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: time to peak (Tmax)	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: apparent terminal elimination rate constant( ? z)	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: Area under drug time curve (AUC)	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: apparent total body clearance (CL / F)	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: apparent distribution volume (VZ / F)	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: elimination half-life (T1 / 2)	0-12week
Secondary	Pharmacokinetic parameters of AK115 in healthy subjects	Pharmacokinetic parameters of AK115 in healthy subjects: mean residence time (MRT), etc	0-12week
Secondary	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
Secondary	Immunogenicity characteristics: the number and percentage of anti AK115 antibody (ADA)	Immunogenicity characteristics: the number and percentage of anti AK115 antibody (ADA)	0-12week
Secondary	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
Secondary	Immunogenicity characteristics: time to ADA positive	Immunogenicity characteristics: time to ADA positive	0-12week