A Clinical Study of AK139 in Healthy Subjects

NCT06947109 | Not Yet Recruiting Phase 1

• 1 other identifier: AK139-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  The incidence of AEs . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  Baseline to week 12

Secondary Outcomes (5)

• Peak concentration (Cmax)

  Week 0 to week 12

• Time to peak (Tmax)

  Week 0 to week 12

• Area under the curve (AUC)

  Week 0 to week 12

• Half-life (t1/2)

  Week 0 to week 12

• Anti-drug antibody (ADA)

  Week 0/2/4/8/12

Study Arms (2)

AK139 regimen

ACTIVE COMPARATOR

Drug: AK111

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator.

Placebo

AK111 DRUG

The study will use dose escalation scheme. Before proceeding to randomize the next group of subjects, the safety data from all subjects in the previous dose group must be reviewed and confirmed.

AK139 regimen

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily agree to participate and sign an informed consent form (ICF) before any study procedures begin.
• Male and female healthy subjects aged 18 to 55 at the time of signing the ICF.
• Male weight ≥ 50.0kg, female weight ≥ 45.0kg; Body Mass Index (BMI)=Weight (kg)/Height² (m²), within the range of 19.0\~26.0 kg/m².
• Female subjects with fertility tested negative for pregnancy during the screening period.
• The subjects are able to communicate well with the investigator and understand and comply with the requirements of this study.

You may not qualify if:

• Allergies to AK139 components and any monoclonal antibodies.
• Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening.
• have participated in any drug clinical study within 3 months prior to randomization, or are still within 5 half-lives after the last administration of other investigational drugs (whichever is longer)
• Previously or currently suffering from any diseases of the circulatory, endocrine, neurological, digestive, respiratory, urogenital, blood, immune, psychiatric, or metabolic systems that may interfere with the test results.
• History of parasitic infection.
• Drug abusers or individuals with positive urine drug results during screening.
• Have donated blood or experienced significant blood loss, received blood transfusions, or used blood products 3 months before screening.
• Investigator assessed that it is not suitable to participate in the study.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Guoqin Wang

CONTACT

86 (0760) 8987 3999; global.trials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: May 6, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)