Healthy VolunteersPhase 1NCT05286970

A Clinical Study of AK115 in Healthy Subjects

A Phase 1 study testing AK115 in people with Healthy Volunteers, run by Akeso at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: AK115
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteChina
Study dates: 18 Mar 2022to 28 Sep 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

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
Being tested: AK115, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AK115Drug
Abdominal subcutaneous injection
PlaceboDrug
Abdominal subcutaneous injection

Study groups in NCT05286970
Study group	Role	What they receive
0.5mg AK115 SC	Experimental	single-dose Receives: Drug: AK115
1mg AK115or placebo SC	Experimental	single-dose Receives: Drug: AK115; Drug: Placebo
3mg AK115or placebo SC	Experimental	single-dose Receives: Drug: AK115; Drug: Placebo
10mg AK115or placebo SC	Experimental	single-dose Receives: Drug: AK115; Drug: Placebo
30mg AK115or placebo SC	Experimental	single-dose Receives: Drug: AK115; Drug: Placebo
60mg AK115or placebo SC	Experimental	single-dose Receives: Drug: AK115; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (12)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202228 Sep 2022

First posted18 Mar 2022
Study start18 Mar 2022
Primary completion28 Sep 2022
Study completion28 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by AkesoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05286970
Sponsor's protocol ID: AK115-101
Status last verified: Feb 2025
First submitted: 3 Mar 2022
Last updated: 28 Feb 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40297315

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05286970
Acronym / sponsor ID: AK115-101
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: AkesoIndustry (pharma, biotech, devices)
Study start: 18 Mar 2022 (actual)
Primary completion: 28 Sep 2022 (actual)
Study completion: 28 Sep 2022 (actual)
First posted: 18 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
0.5mg AK115 SC	Experimental	Drug: AK115single-dose
1mg AK115or placebo SC	Experimental	Drug: AK115, Drug: Placebosingle-dose
3mg AK115or placebo SC	Experimental	Drug: AK115, Drug: Placebosingle-dose
10mg AK115or placebo SC	Experimental	Drug: AK115, Drug: Placebosingle-dose
30mg AK115or placebo SC	Experimental	Drug: AK115, Drug: Placebosingle-dose
60mg AK115or placebo SC	Experimental	Drug: AK115, Drug: Placebosingle-dose

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AK115Abdominal subcutaneous injection	Drug	0.5mg AK115 SC, 10mg AK115or placebo SC, 1mg AK115or placebo SC, 30mg AK115or placebo SC, 3mg AK115or placebo SC, 60mg AK115or placebo SC
PlaceboAbdominal subcutaneous injection	Drug	10mg AK115or placebo SC, 1mg AK115or placebo SC, 30mg AK115or placebo SC, 3mg AK115or placebo SC, 60mg AK115or placebo SC

Primary outcome

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

12 secondary outcomes

Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
Pharmacokinetic parameters of AK115 in healthy subjects
Time frame: 0-12week
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)
Time frame: 0-12week
Immunogenicity characteristics: the number and percentage of neutralizing antibody (NAB) positive subjects
Time frame: 0-12week
Immunogenicity characteristics: time to ADA positive
Time frame: 0-12week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Derived from this study: PubMed 40297315Zhang 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AK115 in people with Healthy Volunteers, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity classification of adverse events (time frame: 0-12week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05286970, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.