CompletedNCT05286970Updated Feb 28, 2025

A Clinical Study of AK115 in Healthy Subjects

A Phase 1 interventional study of AK115 and Placebo in Healthy Volunteers, sponsored by Akeso. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Akeso · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 studied

Healthy Volunteers

In context

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 42 participants (actual)

Study arms

Experimental
0.5mg AK115 SC
single-dose
Drug: AK115
Experimental
1mg AK115or placebo SC
single-dose
Drug: AK115 · Drug: Placebo
Experimental
3mg AK115or placebo SC
single-dose
Drug: AK115 · Drug: Placebo
Experimental
10mg AK115or placebo SC
single-dose
Drug: AK115 · Drug: Placebo
Experimental
30mg AK115or placebo SC
single-dose
Drug: AK115 · Drug: Placebo
Experimental
60mg AK115or placebo SC
single-dose
Drug: AK115 · Drug: Placebo

Interventions

DrugAK115
Abdominal subcutaneous injection
DrugPlacebo
Abdominal subcutaneous injection

What researchers measure

Primary outcomes

Incidence and severity classification of adverse events
Incidence and severity classification of adverse events
Time frame: 0-12week

Secondary outcomes

Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: peak concentration (Cmax)
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: time to peak (Tmax)
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: apparent terminal elimination rate constant（ λ z)
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: Area under drug time curve (AUC)
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: apparent total body clearance (CL / F)
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: apparent distribution volume (VZ / F)
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: elimination half-life (T1 / 2)
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Pharmacokinetic parameters of AK115 in healthy subjects: mean residence time (MRT), etc
Time frame: 0-12week
Changes in serum total nerve growth factor (NGF) levels from baseline.
Changes in serum total nerve growth factor (NGF) levels from baseline.
Time frame: 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)
Time frame: 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
Time frame: 0-12week
Immunogenicity characteristics: time to ADA positive
Immunogenicity characteristics: time to ADA positive
Time frame: 0-12week

Study locations

1 site

Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan 650000, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05286970
Lead sponsor: Akeso
Responsible party: Sponsor
First posted: Mar 18, 2022
Start date: Mar 18, 2022
Primary completion: Sep 28, 2022
Completion: Sep 28, 2022
Last update: Feb 28, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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