NCT07936708
SA030 Injection in Healthy Participants
StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial
Free. We email you which fields changed when ClinicalTrials.gov updates this record.
Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Approximatly 9 months
Number of participants with clinically significant laboratory abnormalities
Timeframe: Approximatly 9 months
Secondary (10)
Peak plasma concentration (Cmax)
Time to peak plasma concentration (Tmax)
Plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
Elimination half-life (t1/2)
Changes in BMI
Show 5 moreShow less
Changes in body fat content
Changes in hepatic fat content
Changes in ALK7 expression
Number of participants with anti-SA030 antibodies (immunogenicity)
Change in QTcF relative to baseline and relative to placebo compared to baseline
Arms and interventions
SA030 Injection, 100 mgExperimental
Single subcutaneous injection of SA030 at 100 mg dose, one-time administration.
SA030 Injection, 200mgExperimental
Single subcutaneous injection or SA030 at 200 mg dose, one-time administration.
SA030 Injection, 400mgExperimental
Single subcutaneous injection or SA030 at 400 mg dose, one-time administration.
placeboPlacebo comparator
Single subcutaneous injection of placebo, one-time administration.
Drugs: Experimental: 100mg, Experimental: 200mg, Experimental: 400mg, Placebo
Sites
1 site in 1 country
- The First Bethune Hospital of Jilin UniversityChangchun, Jilin, China