Clinical trial NCT06548997: A Phase I Study of GZR18 Injection in Healthy Subjects
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GZR18 Injection in Healthy Subjects Following Single Dose and Once-weekly Dose for 2 Consecutive Weeks Until Reaching the Target Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Overweight and Obesity
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.


Eligibility criteria: Inclusion Criteria:

* 1. Subjects sign informed consent voluntarily.
* 2. Chinese adult subjects, male or female.
* 3. Age 18-55 at screening (both included).
* 4. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg).
* 5. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.

Exclusion Criteria:

* 1. History of dizziness with blood and needles.
* 2. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases.
* 3. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening.
* 4. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening.
* 5. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic).
* 6. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.

Primary outcomes:
measure: TEAE
timeFrame: after 28/35 days of treatment
Secondary outcomes:
measure: Cmax
timeFrame: 28/35 days
measure: AUClast
timeFrame: 28/35 days
measure: AUC0-inf
timeFrame: 28/35 days
measure: Tmax
timeFrame: 28/35 days
measure: λz
timeFrame: 28/35 days
measure: t1/2
timeFrame: 28/35 days
measure: tlag
timeFrame: 28/35 days
measure: CL/F
timeFrame: 28/35 days
measure: Vz/F
timeFrame: 28/35 days
measure: AUC%extra
timeFrame: 28/35 days
measure: MRT
timeFrame: 28/35 days
measure: AUCglucose0-14h
timeFrame: 28/35 days
measure: AUCc-peptide0-14h
timeFrame: 28/35 days
measure: AUCinsulin0-14h
timeFrame: 28/35 days
measure: body weight
timeFrame: 28/35 days
measure: body mass index (BMI）
timeFrame: 28/35 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gan & Lee Pharmaceuticals Co., Ltd
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Liyuan Zhao, Ph.D
role: STUDY_DIRECTOR
References: