- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07670897
Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Yunda Zhuge
- Telefonnummer: 010-56456739
- E-post: zhugeyunda@ganlee.com
Studera Kontakt Backup
- Namn: Shiyun Lai
- Telefonnummer: 010-56456739
- E-post: shiyun.lai@ganlee.com
Studieorter
-
-
Shandong
-
Linyi, Shandong, Kina, 276000
- Gan & Lee Pharmaceuticals Shandong Co., Ltd.,
-
Kontakt:
- Yunda Zhuge
- Telefonnummer: 010-56456739
- E-post: zhugeyunda@ganlee.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
1. Voluntarily sign the Informed Consent Form (ICF), be willing to accept subcutaneous injection, fully understand the study content, procedures and potential adverse reactions, and be able to comply with the contraindications and restrictions specified in this protocol.
2. Male, aged 18 to 50 years (inclusive) at the time of ICF signing. 3. Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 24.0 kg/m² (inclusive) at screening.
4. Male participants of childbearing potential have no plans for conception, voluntarily adopt effective contraceptive measures, and have no sperm donation plans from the date of ICF signing until 4 weeks after dosing.
Exclusion Criteria:
1. Have an allergic constitution, or a history of allergic diseases such as bronchial asthma and eczema (except for mild seasonal allergy); or have a history of severe food allergy (e.g., laryngeal edema, shock); or known allergy, hypersensitivity or intolerance to the investigational medicinal product (IMP) or similar products or their excipients; or have a clinically significant history of drug allergy or atopic allergic diseases.
2. Findings from physical examination, vital signs, routine laboratory tests, 12-lead electrocardiogram (ECG), chest imaging and other assessments at screening are judged to be clinically significant by the investigator.
3. Have special dietary requirements and are unable to comply with the standardized diet.
4. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.
5. The participant is an employee of the investigator or the study center, or a family member of an employee or the investigator; or the participant has other factors that, in the investigator's opinion, make him/her unsuitable for participation in the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: GZR4 injection A
|
GZR4 s.c., single-dose
|
|
Experimentell: GZR4 injection B
|
GZR4 s.c., single-dose
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cmax
Tidsram: Day1-Day29
|
Peak concentration following single administration of GZR4
|
Day1-Day29
|
|
AUC₀-t
Tidsram: Day1-Day29
|
Area under the plasma concentration-time curve from time zero to the last quantifiable sampling time point t after single administration of GZR4
|
Day1-Day29
|
|
AUC₀-∞
Tidsram: Day1-Day29
|
Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4
|
Day1-Day29
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Tmax
Tidsram: Dag 1-Dag 29
|
Dag 1-Dag 29
|
|
t1/2
Tidsram: Day1-Day29
|
Day1-Day29
|
|
AUC_%Extrap
Tidsram: Day1-Day29
|
Day1-Day29
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- GZR4-T2D-106
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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