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
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
Treatments tested in this trial
- AK104 (New Site)
- AK104 (Original Site)
Treatment groups
158 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov