This is a placebo-controlled, double-blind trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of TQF6422 Injection in overweight or obese healthy participants.
Chinese male or female trial participants aged ≥18 years (inclusive) and ≤55 years (inclusive).
Participant body weight ≥50 kg, with body-mass index (BMI) of 24-40 kg/m² (end-points included).
At screening, the following findings shall be within normal limits, or deemed clinically insignificant by the Investigator despite being abnormal and not meeting
Negative human immunodeficiency virus antibody (HIV-Ab) test.
Non-childbearing potential: including surgical sterilization performed at least 6 weeks prior to screening visit (documented tubal ligation, hysterectomy, or bilateral oophorectomy), or post-menopausal status for ≥12 months prior to screening visit (confirmed by follicle-stimulating hormone (FSH) level ≥40 IU/L); OR
Child-bearing potential: must be non-pregnant and non-lactating, and must agree to use effective (at least one highly-effective) non-pharmacological contraceptive measures from 14 days before screening, throughout the study period, and for 6 months after study drug administration. Serum pregnancy test shall be negative with human chorionic gonadotropin (hCG) <5 mIU/mL at screening and baseline (D-1). Participants shall not donate ova during this period.
Male participants with female partners of child-bearing potential must agree to use effective (at least one highly-effective) non-pharmacological contraceptive measures from 14 days before screening, throughout the study period, and for 6 months after study drug administration. Male participants shall not donate sperm during this period.
Parallel
TQF6422 Injection
DrugTQF6422 injection is an anti-ActRIIA/IIB monoclonal antibody.
TQF6422 Placebo
DrugA placebo matching TQF6422 Injection in appearance, dosage form, and route of administration, but containing no active ingredient.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time-to-maximum concentration( Tmax)
Time-to-maximum concentration of TQF6422
Peak concentration (Cmax)
Maximum plasma drug concentration of TQF6422
Area under the concentration-time curve(AUC)
Area under the plasma concentration-time curve of TQF6422
Apparent volume of distribution (Vd/F)
Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability.
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