Obesity / Overweight
Conditions
Brief summary
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.
Interventions
DRUGTQF6422 Injection
TQF6422 injection is an anti-ActRIIA/IIB monoclonal antibody.
DRUGTQF6422 Placebo
A placebo matching TQF6422 Injection in appearance, dosage form, and route of administration, but containing no active ingredient.
Sponsors
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Chinese male or female trial participants aged ≥18 years (inclusive) and ≤55 years (inclusive). 2. Participant body weight ≥50 kg, with body-mass index (BMI) of 24-40 kg/m² (end-points included). 3. At screening, the following findings shall be within normal limits, or deemed clinically insignificant by the Investigator despite being abnormal and not meeting
Exclusion criteria
vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and clinical laboratory tests (including but not limited to hematology, urinalysis, serum biochemistry, coagulation function, serological virology, and thyroid function). 4. Negative human immunodeficiency virus antibody (HIV-Ab) test. 5. For female participants: 1. 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 2. 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. 6. 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. 7. Voluntarily provide written informed consent prior to trial participation, with full understanding of trial content, procedures and potential adverse reactions; able to communicate adequately with the Investigator, and understand and comply with all study-related requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | Baseline up to day84 in part A and day112 in part B. | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid parameters | Up to day 84 after administration in part A;Up to day 112 after administration in part B. | Changes and percentage changes in Lipid parameters after administration. |
| Anti-drug antibody (ADA) levels | Predose to Day 84 after administration in part A ；Predose to Day 112 after administration in part B. | Test ADA status in biological sample via validated methodology. |
| Time-to-maximum concentration( Tmax) | Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B. | Time-to-maximum concentration of TQF6422 |
| Peak concentration (Cmax) | Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B. | Maximum plasma drug concentration of TQF6422 |
| Area under the concentration-time curve(AUC) | Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B. | Area under the plasma concentration-time curve of TQF6422 |
| Apparent volume of distribution (Vd/F) | Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B. | Apparent Volume of Distribution at the Terminal Phase divided by Bioavailability. |
| Apparent Clearance (CL/F) | Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B. | The apparent volume of plasma from which the drug is completely removed per unit time, adjusted for bioavailability |
| Plasma half life (t1/2) | Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B. | The time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half of TQF6422 |
| Change from baseline and percentage change from baseline in total body weight | at Week 4, Week 8, and Week 12 following the last administration. | Body weight will be measured with shoes and headwear removed. |
| Change from baseline and percentage change from baseline in waist circumference | at Week 4, Week 8, and Week 12 following the last administration. | Waist circumference should be measured in the horizontal plane, at the midpoint between the inferior margin of the last palpable rib and the top of the iliac crest. |
| Change from baseline in total fat mass (TFM) | at Week 4, Week 8, and Week 12 following the last administration. | Change from baseline in the TFM will be measured by dual-energy X-ray absorptiometry (DXA) after the last dose |
| Change from baseline in total lean body mass (LBM) | at Week 4, Week 8, and Week 12 following the last administration. | Change from baseline in the LBM will be measured by dual-energy X-ray absorptiometry (DXA) after the last dose |
| Myostatin and Activin A levels | Up to day 84 after administration in part A;Up to day 112 after administration in part B. | Determine the changes in serum Myostatin and Activin A levels from baseline at each visit. |
| Fasting plasma glucose | Up to day 84 after administration in part A;Up to day 112 after administration in part B. | Changes and percentage changes in fasting plasma glucose after administration. |
| Glycated hemoglobin (HbA1c) | Up to day 84 after administration in part A;Up to day 112 after administration in part B. | Changes and percentage changes in HbA1c after administration. |
| Fasting insulin | Up to day 84 after administration in part A;Up to day 112 after administration in part B. | Changes and percentage changes in fasting insulin after administration. |
Countries
China
Contacts
CONTACTXuening Li, Master
Outcome results
None listed