This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Administered SC.
Administered SC.
Administered SC.
Administered SC.
Pharmaron CPC, Inc
Baltimore, Maryland, United States
RECRUITINGNumber of treatment adverse events
The relationship of each adverse event to the investigational product was assessed by the investigator
Time frame: Predose up to 6 weeks (Part A) & 9 weeks (Part B)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812
PK: AUC of BGM1812
Time frame: Predose through week 6 (Part A) & week 9 (Part B)
PK: Maximum Observed Concentration (Cmax) of BGM1812
PK: Cmax of BGM1812
Time frame: Predose through week 6 (Part A) & week 9 (Part B)
Pharmacodynamics (PD): Change from baseline in fasting body weight
Pharmacodynamics (PD): Change from baseline in fasting body weight
Time frame: Predose through week 6 (Part A) & week 9 (Part B)
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