Health TrialsbyHealthPanel

A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Participations

ConditionHealthy Male Adults Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorAkeso

About this trial

This study is to evaluate the pharmacokinetic (PK) similarity of AK104 (an anti-PD-1/CTLA-4 bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to provide signed informed consent prior to the trial and fully understand the trial content, procedures, and potential adverse reactions.

Able to complete the study as required by the trial protocol.

Males aged 18 to 45 years.

Body Mass Index (BMI) is 19.0 ~ 26.0 kg/m² and body weight is 55.0 ~ 75.0 kg.

Disqualifiers

Have a history of diseases of the digestive, respiratory, cardiovascular, endocrine, urinary, nervous, or hematologic systems, or metabolic disorders, which, in the investigator's opinion, is still clinically significant at the time of screening.

Have a history of malignancy (excluding successfully resected cutaneous squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ with no evidence of metastasis).

Have a history of autoimmune disease (including personal or family history of hereditary immunodeficiency).

Have a history of tuberculosis or clinical manifestations suggestive of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK104 (New Site)

    Drug

    AK104 (New Site) 0.2mg/kg

  • AK104 (Original Site)

    Drug

    AK104 (Original Site) 0.2mg/kg

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: AK104 (New site)Experimental treatment 1 intervention
Group B: AK104 (Original site)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area under the plasma concentration-time curve (AUC0-infinity)

Time frame
From pre-dose to day 22

Secondary outcomes

1

Area under the plasma concentration-time curve (AUC0-t)

Time frame
From pre-dose to day 22
2

Maximum plasma concentration (Cmax)

Time frame
From pre-dose to day 22
3

Volume of distribution (V)

Time frame
From pre-dose to day 22
4

Clearance (CL)

Time frame
From pre-dose to day 22

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: