A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:
- Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?
- How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?
In the first Part of the study:
Participants will:
• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
In the second Part of the study:
Participants will:
• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity.
In addition, the study will investigate the pharmacokinetics of the drug ZP6590.
The trial is divided in two parts:
SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
After informed consent has been obtained, eligibility of the participants will be assessed during a screening visit.
SAD- and MAD-Part: Eligible participants will be admitted to the site in the morning on Day before dosing and will have ambulatory visits or remain under in-house conditions after dosing.
Safety evaluation for dose escalation:
The safety and exposure assessments of each cohort will take place before dose escalation to the next dose level will start.
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
Vaihe
Vaihe
- Varhainen vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Regulatory Affairs Department Regulatory Affairs Department, MDRA
- Puhelinnumero: +49213140180
- Sähköposti: clinicaltrialservices@profil.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Regulatory Affairs Department Regulatory Affairs Department
- Puhelinnumero: +49213140180
- Sähköposti: clinicaltrialservices@profil.com
Opiskelupaikat
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-
North Rhine-Westphalia
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Neuss, North Rhine-Westphalia, Saksa, 41460
- Rekrytointi
- Profil, Institut für Stoffwechselforschung GmbH
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Ottaa yhteyttä:
- Regulatory Affairs Department Regulatory Affairs Department
- Puhelinnumero: +49213140180
- Sähköposti: clinicaltrialservices@profil.com
-
Ottaa yhteyttä:
- Project Management Project Management
- Puhelinnumero: +49213140180
- Sähköposti: clinicaltrialservices@profil.com
-
Päätutkija:
- Ulrike Hövelmann, MD
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
SAD-Part:
- Male participant
- Age between 18 and 55 years, both inclusive
- Body Mass Index (BMI) between 20.0 and 29.9 kg/m^2, both inclusive
MAD-Part:
- Male participant
- Age between 18 and 60 years, both inclusive
- Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
Exclusion Criteria:
SAD-Part and MAD-Part:
- Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator
- Treatment for weight management within 3 months before randomization in this trial
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Kolminkertaistaa
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Active Comparator: Drug: ZP6590, solution for injection
ZP6590 will be administered as single dose administration and as multiple dose administrations.
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Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
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Placebo Comparator: Placebo, solution for injections
Placebo will be administered as single dose administration and as multiple dose administrations.
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Participants will receive single or multiple subcutaneous dose administrations of Placebo.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Safety and Tolerability
Aikaikkuna: Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial
|
Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD-Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
SAD Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD-Part: From Day 1 to Day 29
|
Peak Plasma Concentration (Cmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD-Part: From Day 1 to Day 29
|
Time to Peak Plasma Concentration (Tmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD-Part: From Day 1 to Day 29
|
Terminal rate constant (λz)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD-Part: From Day 1 to Day 29
|
Terminal half-life (t½)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD-Part: From Day 1 to Day 29
|
Apparent volume of distribution during terminal phase (Vz/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
Aikaikkuna: SAD-Part: From Day 1 to Day 29
|
apparent total clearance of ZP6590 from plasma for SAD cohorts (CL/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
Area under the plasma concentration versus time curve from 0 to trough (AUCτ)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
Trough concentration measured predose for MAD cohorts (Cτ)
|
MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal rate constant (λz)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal half-life (t½)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent volume of distribution during terminal phase (Vz/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent total clearance of ZP6590 from plasma at steady state (SS) for MAD-cohorts (CLss/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
Aikaikkuna: MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Mean residence time of plasma ZP6590 concentration at steady state (SS) for MAD cohorts (MRTss)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Ulrike Hövelmann, Profil Institut für Stoffwechselforschung GmbH
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Arvioitu)
Ensisijainen valmistuminen
Opintojen valmistuminen (Arvioitu)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
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