A Phase I Clinical Trial of AK115 in Healthy Subjects

• Sponsor: Akeso (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05286970
• Collaborator: (none)
• Enrollment: 42
• Arms: 6
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: AK115; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.5mg AK115 SC	Drug: AK115; Abdominal subcutaneous injection
Experimental: 1mg AK115or placebo SC	Drug: AK115; Abdominal subcutaneous injection; Drug: Placebo; Abdominal subcutaneous injection
Experimental: 3mg AK115or placebo SC	Drug: AK115; Abdominal subcutaneous injection; Drug: Placebo; Abdominal subcutaneous injection
Experimental: 10mg AK115or placebo SC	Drug: AK115; Abdominal subcutaneous injection; Drug: Placebo; Abdominal subcutaneous injection
Experimental: 30mg AK115or placebo SC	Drug: AK115; Abdominal subcutaneous injection; Drug: Placebo; Abdominal subcutaneous injection
Experimental: 60mg AK115or placebo SC	Drug: AK115; Abdominal subcutaneous injection; Drug: Placebo; Abdominal subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Incidence and severity classification of adverse events [0-12week]

   Incidence and severity classification of adverse events

Secondary Outcome Measures

1. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: peak concentration (Cmax)

2. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: time to peak (Tmax)

3. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: apparent terminal elimination rate constant（ λ z)

4. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: Area under drug time curve (AUC)

5. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: apparent total body clearance (CL / F)

6. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: apparent distribution volume (VZ / F)

7. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: elimination half-life (T1 / 2)

8. Pharmacokinetic parameters of AK115 in healthy subjects [0-12week]

   Pharmacokinetic parameters of AK115 in healthy subjects: mean residence time (MRT), etc

9. Changes in serum total nerve growth factor (NGF) levels from baseline. [0-12 week]

   Changes in serum total nerve growth factor (NGF) levels from baseline.

10. Immunogenicity characteristics: the number and percentage of anti AK115 antibody (ADA) [0-12week]

    Immunogenicity characteristics: the number and percentage of anti AK115 antibody (ADA)

11. Immunogenicity characteristics: the number and percentage of neutralizing antibody (NAB) positive subjects [0-12week]

    Immunogenicity characteristics: the number and percentage of neutralizing antibody (NAB) positive subjects

12. Immunogenicity characteristics: time to ADA positive [0-12week]

    Immunogenicity characteristics: time to ADA positive

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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;

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

2. 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);

3. 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,

4. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Akeso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Akeso
• ClinicalTrials.gov Identifier: NCT05286970
• Other Study ID Numbers: AK115-101
• First Posted: Mar 18, 2022
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 18, 2022