A Phase 1 Ethnobridging TriaL of AGA2118 in Healthy Japanese, Chinese, and Caucasian ParticipantS (ATLAS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAngitia Incorporated Limited
About this trial
This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy males or females, aged 18 to 65 years
25-hydroxyvitamin D ≥30 ng/mL and agree to taking calcium and vitamin D supplements during the study
Meet the criteria for Japanese, Chinese, or Caucasian ethnicity
Disqualifiers
Participating or have participated in another clinical trial within the past 6 months
Any bone fracture within the past 6 months
History of myocardial infarction or stroke within the past 12 months
Malignancy within the past 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
AGA2118
DrugParticipants will receive AGA2118 administered by subcutaneous injection
Treatment groups
30 Participants
are divided into 5 treatment groupsGroup A: Cohort 1 (Japanese)Experimental treatment 1 intervention
Group B: Cohort 2 (Japanese)Experimental treatment 1 intervention
Group C: Cohort 3 (Japanese)Experimental treatment 1 intervention
Group D: Cohort 4 (Caucasian)Experimental treatment 1 intervention
Group E: Cohort 5 (Chinese)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum concentration (Cmax)
Cmax of AGA2118 after dosing
Time frame
Day 1 to up to the end of study (85 days post-dose)2
Time to maximum concentration (Tmax)
Tmax of AGA2118 after dosing
Time frame
Day 1 to up to the end of study (85 days post-dose)3
Area under the concentration-time curve (AUC)
AUC of AGA2118 after dosing
Time frame
Day 1 to up to the end of study (85 days post-dose)4
Half-life (t1/2)
t1/2 of AGA2118 after dosing
Time frame
Day 1 to up to the end of study (85 days post-dose)Secondary outcomes
1
Treatment-emergent adverse events (TEAEs)
Occurrence of TEAEs
Time frame
Baseline to the end of study (85 days post-dose)Sponsors and contacts
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Source ClinicalTrials.gov