This is a Phase I, randomized, double-blind, placebo-controlled, single-dose study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011. Participants will be randomized to receive a single subcutaneous dose of YN-011 1 mg, YN-011 3 mg, or matching placebo. The study includes screening, approximately 2 days of study-site confinement from the day before dosing to 24 hours after dosing, and outpatient follow-up for 4 weeks. Assessments include safety monitoring, PK blood sampling, PD evaluations, and immunogenicity testing.
This is a Phase I, randomized, double-blind, placebo-controlled, single-dose, parallel-group study in healthy adult participants in Brazil to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of YN-011 following subcutaneous administration. The study will be conducted at a single clinical study site in Brazil and will enroll approximately 48 healthy adult participants. Participants will be randomized into 2 dose cohorts, a 1 mg cohort and a 3 mg cohort. Within each cohort, participants will be randomized in a 5:1 ratio to receive a single subcutaneous dose of YN-011 or matching placebo. Overall, the study will include 3 treatment groups: YN-011 1 mg, YN-011 3 mg, and placebo. The placebo will be matched in appearance and administered using the same device format in order to maintain blinding. The main objectives of the study are to assess the safety and tolerability of YN-011 after single-dose administration in healthy adult participants, to characterize its PK profile, to evaluate selected PD effects, and to assess immunogenicity. Safety evaluations will include adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and other appropriate clinical assessments. PK assessments will characterize the concentration-time profile of YN-011 after dosing. PD assessments will evaluate the biologic effects of YN-011 after administration. Immunogenicity assessments will evaluate whether participants develop an immune response to YN-011. The study includes a screening period of up to 4 weeks, a study-site confinement period of approximately 2 days, and an outpatient follow-up period of 4 weeks, for a maximum total study duration of approximately 8 weeks per participant. Participants will be admitted to the clinical study site on the day before dosing and will undergo pre-dose assessments to confirm continued eligibility. On Day 1, participants will receive a single subcutaneous injection of YN-011 1 mg, YN-011 3 mg, or matching placebo in the abdomen using a prefilled auto-injector. During the confinement period, participants will remain under close clinical observation and will receive a controlled diet with specified fasting and fluid intake restrictions around dosing. After completion of the post-dose confinement period, participants will be discharged from the clinical study site and will return for scheduled outpatient follow-up visits for PK blood sampling, safety monitoring, PD evaluations, and immunogenicity assessments. The results of this study are expected to provide clinical information on the safety, PK, PD, and immunogenicity profile of single-dose YN-011 in healthy adult participants in Brazil.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Efsubaglutide alfa will be administered as a single subcutaneous injection at a dose of 1 mg or 3 mg on Day 1 in healthy adult participants. The study drug will be administered in the abdomen using a prefilled auto-injector.
Matching placebo will be administered as a single subcutaneous injection on Day 1 in healthy adult participants. Placebo is identical in appearance and presentation to efsubaglutide alfa and will be administered in the abdomen using a matching prefilled auto-injector.
A2Z Clinical Centro Avançado de Pesquisa Clínica LTDA
Valinhos, São Paulo, Brazil
Maximum Observed Plasma Concentration (Cmax) of YN-011
Time frame: Predose through Day 29
Time to Maximum Observed Plasma Concentration (Tmax) of YN-011
Time frame: Predose through Day 29
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of YN-011
Time frame: Predose through Day 29
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of YN-011
Time frame: Predose through Day 29
Terminal Elimination Half-Life (t1/2) of YN-011
Time frame: Predose through Day 29
Incidence and severity of adverse events
Incidence and severity of adverse events, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: From informed consent through Day 29
Clinically significant changes in vital signs, clinical laboratory tests, and 12-lead electrocardiograms
Clinically significant changes in vital signs, clinical laboratory tests, including hematology, biochemistry, amylase, lipase, and urinalysis, and 12-lead electrocardiograms.
Time frame: Baseline through Day 29
Change from baseline in fasting plasma glucose
Time frame: Baseline through Day 29
Change From Baseline in Body Weight
Time frame: Baseline through Day 29
Incidence of anti-drug antibodies and neutralizing antibodies
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs), if ADA positive.
Time frame: Baseline through Day 29
Correlation Between AUC0-inf of YN-011 and Change From Baseline in Fasting Plasma Glucose at Day 29
Time frame: Baseline and Day 29
Correlation between AUC0-inf of YN-011 and change from baseline in body weight at Day 29
Time frame: Baseline and Day 29
Comparison of AUC0-inf of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Comparison of AUC0-inf of YN-011 between healthy adult Brazilian participants in this study and existing healthy-participant data from the Chinese Phase I clinical program.
Time frame: Predose through Day 29
Comparison of AUC0-t of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Comparison of AUC0-t of YN-011 between healthy adult Brazilian participants in this study and existing healthy-participant data from the Chinese Phase I clinical program.
Time frame: Predose through Day 29
Comparison of Cmax of YN-011 Between Healthy Adult Brazilian Participants and Chinese Phase I Healthy Participants
Comparison of Cmax of YN-011 between healthy adult Brazilian participants in this study and existing healthy-participant data from the Chinese Phase I clinical program.
Time frame: Predose through Day 29
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