- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07841860
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets as a Single Dose in Healthy Participants and Multiple Doses in Obese Participants - a Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study
This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Jing He
- Numero di telefono: +86-0518-82342973
- Email: jing.he@hengrui.com
Backup dei contatti dello studio
- Nome: Xuehu Gao
- Numero di telefono: +86-0518-82342973
- Email: xuehu.gao@hengrui.com
Luoghi di studio
-
-
Shandong
-
Jinan, Shandong, Cina, 250013
- Jinan Central Hospital
-
Investigatore principale:
- Qing Wen
-
Contatto:
- Qing Wen
- Numero di telefono: +86-0531-55865012
- Email: wenq0619@126.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
- The age range is from 18 to 55 years old (inclusive at both ends).
- Weight ≥ 50.0 kg.
- They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).
Exclusion Criteria:
- During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
- The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
- During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
- Diabetes (except gestational diabetes).
- Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ).
- Those who have had or currently have the following diseases with clinical significance (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cardiovascular diseases), and who, in the judgment of the investigators, are not suitable to participate in this trial.
- Those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine); or those who had taken any alcohol-containing products within 48 hours before the administration; or those with a positive alcohol breath test result.
- Screening criteria: Daily smoking quantity greater than 5 cigarettes within the past 3 months or use of any tobacco product within 48 hours prior to administration.
- Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result.
- Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: HRS-1596 Group
HRS-1596, healthy subjects or obese subjects. |
HRS-1596. |
|
Comparatore placebo: HRS-1596 Placebo Group
HRS-1596 placebo, healthy subjects or obese subjects. |
HRS-1596 placebo. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
The incidence and severity of adverse events (AEs)
Lasso di tempo: Screening period up to Day 84.
|
Screening period up to Day 84.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
The maximum plasma concentration (Cmax)
Lasso di tempo: Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Time to maximum plasma concentration (Tmax)
Lasso di tempo: Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Terminal half-life (t1/2)
Lasso di tempo: Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Anti-HRS-1596 Antibodies (ADAs)
Lasso di tempo: Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
|
Fasting plasma glucose (FPG)
Lasso di tempo: Post-dose at Day 1 to Day 84.
|
Post-dose at Day 1 to Day 84.
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HRS-1596-101
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .