A Study of TG103 in Chinese Healthy Adult Subjects

NCT03990090 | Completed Phase 1

• 1 other identifier: TG103/201901
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The main purposes of this study are to determine:

1. 1.To assess the safety and tolerability of a single subcutaneous injection of different doses of TG103 in healthy Chinese adult subjects.
2. 2.The pharmacokinetic and pharmacodynamic characteristics of a single subcutaneous injection of different doses of TG103 in healthy Chinese adult subjects were assessed.

Conditions

Healthy

Keywords

TG103; Pharmacokinetic; Pharmacodynamic; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through Day 28

Secondary Outcomes (9)

• Area under the plasma concentration versus time curve (AUC)

  0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h

• Peak Plasma Concentration (Cmax)

  0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h

• Time to maximum plasma concentration（Tmax）

  0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours

• Half time (t1/2)

  0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours

• Apparent clearance (CL/F)

  0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours

Study Arms (2)

TG103

EXPERIMENTAL

Escalating doses of TG103 administered subcutaneously (SC) once in healthy participants.

Drug: TG103

Placebo

PLACEBO COMPARATOR

Placebo administered SC once in healthy participants.

Drug: Placebo

Interventions

TG103 DRUG

Administered SC

TG103

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old and ≤ 65 years old, male or female;
• Medical history, physical examination, vital signs, 12-lead ECG and laboratory examination, imaging examination (thyroid color Doppler ultrasound, abdominal color Doppler ultrasound, chest X-ray) in the normal range, or not in the normal range but the researchers consider they have no clinical significance;
• The weighing no less than 50 kg in male subjects, and no less than 45 kg in female subjects , body mass index (BMI) between 18.9 and 27.9 kg/m2 (including boundary values)
• Fasting blood glucose is between 3.9-6.1 mmol/L (excluding the boundary value), and HbA1c is \<5.7%;
• Subjects must use reliable methods of contraception throughout the study period and avoid pregnancy in women or pregnancy in male subjects' partners at least 3 months after dosing;
• The subject is fully aware of the test content and possible adverse reactions, and has the ability to communicate properly with the researcher while complying with the research requirements;
• Voluntarily participate in the study and sign the informed consent form.

You may not qualify if:

• Have a history of severe drug or food allergies, or who may be allergic to the test drug by the investigator;
• Have undergone major surgery within 3 months prior to the trial, or have experienced severe infection within 4 weeks prior to the trial;
• Have diabetes, thyroid dysfunction or other endocrine diseases that may affect blood sugar metabolism;
• Individual or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary medullary cancer;
• Those with history of malignant tumors and mental illness, depression, anxiety, and epilepsy disease.
• Drugs and drug abusers in the past three years;
• Vaccination within 28 days prior to the trial or planned to be vaccinated within 1 week of receiving the study drug;
• Has one or more positive tests in Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti- Treponema pallidum-specific antibody;
• Lost more than 400 ml of blood due to blood donation or other reasons within 3 months before the test;
• Apply a glucagon-like peptide-1(GLP-1 )analogue, a glucagon-like peptide-1(GLP-1 )receptor agonist, or any other incretin mimetic 1 month prior to the planned study drug, or other drugs that the investigator believes may affect the trial;
• Those who took prescription or similar over-the-counter medications within 1 month prior to the trial to promote weight loss (eg, orlistat, sibutramine, rimonabant, phenylpropanolamine or chlorpheniramine) ;
• Alcohol intake is more than 21 units of alcohol per week (male) / 14 units of alcohol per week(female) (1 unit ≈ 360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine) 3 months prior to the screening.
• Regular consumption of caffeine more than 600 mg per day in the past 3 months (1 cup of coffee contains about 100 mg of caffeine, 1 cup of tea contains about 30 mg of caffeine, and 1 can of Coke contains about 20 mg of caffeine);
• Those who have taken caffeinated products or drugs within 48 hours prior to the study;
• Taken more than 5 cigarettes per day in the past 3 months;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Jin J, Cui G, Mi N, Wu W, Zhang X, Xiao C, Wang J, Qiu X, Han M, Li Z, Wang L, Lu T, Niu H, Wu Z, Li J. Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects. Eur J Pharm Sci. 2023 Jun 1;185:106448. doi: 10.1016/j.ejps.2023.106448. Epub 2023 Apr 14.

  PMID: 37062422 DERIVED

Study Officials

• jintong li

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• li chen

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 18, 2019
• Study Start: July 29, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)