A Clinical Trial of TQF6422 Injection in Overweight or Obese Healthy Subjects.

NCT07794111 | Not Yet Recruiting Phase 1

• 1 other identifier: TQF6422-1-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity / Overweight

Outcome Measures

Primary Outcomes (1)

• Adverse event rate

  The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

  Baseline up to day84 in part A and day112 in part B.

Secondary Outcomes (16)

• Time-to-maximum concentration( Tmax)

  Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B.

• Peak concentration (Cmax)

  Predose to Day 84 after administration in part A ;Predose to Day 112 after administration in part B.

• 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.

• 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 Clearance (CL/F)

  Predose to Day 84 after administration in part A;Predose to Day 112 after administration in part B.

Study Arms (5)

Part A: TQF6422 Injection (Single Dose)

EXPERIMENTAL

Participants in this arm will receive a single dose of TQF6422 Injection.

Drug: TQF6422 Injection

Part A: TQF6422 Placebo (Single Dose)

PLACEBO COMPARATOR

Participants in this arm will receive a single dose of placebo matching TQF6422 Injection.

Drug: TQF6422 Placebo

Part B: TQF6422 Injection (Once Weekly)

EXPERIMENTAL

Participants in this arm will receive TQF6422 Injection administered once weekly (QW) for multiple doses.

Drug: TQF6422 Injection

Part B: TQF6422 Injection (Once Every 4 Weeks)

EXPERIMENTAL

Participants in this arm will receive TQF6422 Injection administered once every 4 weeks (Q4W) for multiple doses.

Drug: TQF6422 Injection

Part B: TQF6422 Placebo (Once Weekly or Once Every 4 Weeks)

PLACEBO COMPARATOR

Participants in this arm will receive placebo matching TQF6422 Injection administered Once Weekly or Once Every 4 Weeks.

Drug: TQF6422 Placebo

Interventions

TQF6422 Injection DRUG

TQF6422 injection is an anti-ActRIIA/IIB monoclonal antibody.

Part A: TQF6422 Injection (Single Dose); Part B: TQF6422 Injection (Once Every 4 Weeks); Part B: TQF6422 Injection (Once Weekly)

TQF6422 Placebo DRUG

A placebo matching TQF6422 Injection in appearance, dosage form, and route of administration, but containing no active ingredient.

Part A: TQF6422 Placebo (Single Dose); Part B: TQF6422 Placebo (Once Weekly or Once Every 4 Weeks)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Negative human immunodeficiency virus antibody (HIV-Ab) test.
• For female participants:
• 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.
• 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.
• Participants meeting any of the following criteria will be excluded from enrollment:
• History of second-degree or higher cardiac conduction block, or PR interval \>220 ms; risk factors or history of torsades de pointes ventricular tachycardia, including but not limited to unexplained syncope, long-QT syndrome, heart failure; OR any abnormal 12-lead ECG at screening judged by the Investigator to increase risks associated with study participation.
• History of gastrointestinal surgery causing malabsorption (except for endoscopic resections such as gastric polypectomy), or long-term use of medications directly affecting gastrointestinal motility.
• Use within 3 months prior to screening, or ongoing use of medications known to significantly affect body weight (regardless of therapeutic indication), including: GLP-1R agonists, GLP-1R/GIPR agonists, GLP-1R/GCGR agonists, systemic corticosteroids (intravenous, oral or intra-articular), metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones (TZDs), tricyclic antidepressants, psychotropic or sedative agents (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, lithium salts).
• Known comorbid diseases affecting the skeletal-muscle system (e.g., myasthenia gravis, muscular dystrophy); or use of any medications or supplements known to affect muscle anabolism/catabolism within 3 months prior to screening.
• Sunburn, scar tissue, tattoos covering \>25 % of total body surface area, open ulcers or branding at screening, judged by the Investigator to interfere with interpretation of cutaneous adverse reactions.
• Clinically-significant infection at screening, including but not limited to upper respiratory tract infection, lower respiratory tract infection, herpes simplex, herpes zoster, requiring antibiotic or antiviral therapy.
• Receipt of live-virus vaccine within 4 weeks prior to randomization, or planned live-virus vaccination during the study.
• Surgical procedure performed within 4 weeks prior to randomization, or planned surgery during the study.

Sponsors & Collaborators

• Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xuening Li, Master

CONTACT

86-21-31587862; li.xuening@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

CN (1)